5-10
Associate Manager/Manager, Technical Operations
10/6/2025
The Associate Manager will prepare and review technical transfer documents and validation protocols, ensuring compliance with regulatory guidelines. They will also provide technical expertise for investigations and lead day-to-day technical operations for commercial drug product manufacturing.
Salary
100000 - 120000 USD
Working Hours
40 hours/week
Company Size
201-500 employees
Language
English
Visa Sponsorship
No
About The Company
Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options.
Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are intensely committed to developing products that meaningfully improve the lives of patients and provide additional therapeutic options for physicians.
About the Role
<p><span data-contrast="none">Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at </span><a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D9IV8MzSvfOHVeWvrQ7Gpyyjf8oh2YbOImEae8XHfJeeKdWb5iMTG_i6gTGCiHtoMzE1iVTUEQk7IBNDvtrd8dbwJfMAYLK1NiNGH8FOf8LVClDRvtC2QLJLwxcJsj8r1Ife70mjBMpRU8D5q5PfAvDP5AbMwldlIcg5842srmwDavyrAg8tK_VpiNRaKqPlOSPLrCg1Yr2Gqdo5K6iwgZGVlm_WvFI8bMuPXMrqlgRQ%3D&data=05%7C02%7Cmsiegel%40axsome.com%7Cb0ad9a0787784e7305e308dda9c74deb%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C638853395639171980%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=dWf%2FLVmCejjY3pM4XQok9nH8pF%2BfGwqWCZ8QwdWpTGQ%3D&reserved=0"><strong><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">www.axsome.com</span></span></strong></a><span data-contrast="none"> and follow us on </span><a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DgkOAMVaudmIbjNO4LWBtZ25_8dkwL1L91EK22smznktgIMuoh5PltUd03J1ZN68KtUufEmLQRMgUjKqoa2Pb1ADSKI0zgay-rDcXd0R2wsbi9WIetngm8x8P1QX9OxhZQzuoPJMXr0UXnyGnIAbSvjwOT0oODGh2y6eODJbInNknBhQ4fXiSCd0LwP8PlS9T_Er2Q-RAoqsN_pVSx0k80cO9ivcvtqdJxZGSzZ37Ytmfmq-AThjSdP9ltWSUa2Fx&data=05%7C02%7Cmsiegel%40axsome.com%7Cb0ad9a0787784e7305e308dda9c74deb%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C638853395639206174%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ZofAOfLit%2FDztSC9U2W1xpx9HHF9z5bb4r1JDK9%2FVzo%3D&reserved=0"><strong><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">LinkedIn</span></span></strong></a><span data-contrast="none"> and </span><a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DU4SjZsngAmgWDPNMBXhPfrWmLydithQ9boBRvsxUVxU58ik7Xm8tTepHofb6vjZMJpx1MvqLvCWWZ1wdmggQxeoNBfHWoTcIMhguJ4Da2DlcZj5Ye9BIcFvHHFTGURb_iGqk28bMXOs7pE8QmOShf7wSgJ0OVuMRyY31jlih0__WG9Q4dmEjE86yUY_8J0qo&data=05%7C02%7Cmsiegel%40axsome.com%7Cb0ad9a0787784e7305e308dda9c74deb%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C638853395639221688%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Y85uAjK%2B8ysZNvbrHQAmApGPYT7mUKwtYyw%2FV0cvCcE%3D&reserved=0"><strong><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">X</span></span></strong></a><span data-contrast="none">.</span></p>
<p><strong><span data-contrast="none">About This Role</span></strong><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p>
<p><span data-contrast="none">Axsome Therapeutics is seeking a results-driven Associate Manager, Technical Operations with experience in pharmaceutical manufacturing and process validation that is adept in applying advanced statistical methods (ANOVA, MANOVA, process capability) to evaluate process consistency and improve quality outcomes. </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p>
<p><em><span data-contrast="none"><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[469777841,"Century Gothic",469777842,"Century Gothic",469777843,"Century Gothic",469777844,"Century Gothic",469769226,"Century Gothic",268442635,"24",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">This role is based at </span><span data-ccp-charstyle="normaltextrun">Axsome’s</span><span data-ccp-charstyle="normaltextrun"> HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. </span></span></em><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p>
<p><strong><span data-contrast="none">Job Responsibilities and Duties</span></strong><span data-contrast="none"> include, but are not limited to, the following:</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Prepare and review technical transfer documents, validation protocols and reports</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Prepare and review Continued Process Verification (CPV) documents including statistical trending, control charting and process capability analysis and play a significant role in continuous improvement efforts</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Provide on-site support and technical leadership for tech transfer and scale up activities and of process performance qualification (PPQ) for new and existent products</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Lead and support day-to-day technical operations for commercial drug product manufacturing, ensuring compliance with cGMP, FDA, EMA, and ICH guidelines</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Provide technical expertise for investigations of OOS/OOT, deviations, identifying root causes and implementing CAPAs</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Perform risk assessments and develop mitigation strategies for process changes, equipment modifications, and supplier changes</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Support post approval regulatory submissions by writing/reviewing relevant sections of regulatory dossiers</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">Work with the internal and external drug product teams and manufacturing site technical leads to develop and communicate tech transfer plans</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">Collaborate with cross-functional teams (QA, QC, Regulatory, R&D, Supply Chain) to resolve technical issues and drive operational excellence</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="none">Ensure a high level of current technical knowledge is maintained within the development team by implementing new technical developments and practices in the industry as required and where needed</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="none">Design complex technical projects or investigations, interpret diverse data and results, and provide recommendations for the next steps</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="none">Implement statistical tools (ANOVA, Statistical Process Control) for data-driven decision-making and process improvement</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="none">Initiate and review change controls and SOPs as needed</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<p><strong><span data-contrast="none">Requirements / Qualifications</span></strong><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Master’s Degree in chemical engineering or pharmaceutical engineering with minimum of 4 years</span> <span data-contrast="none">of directly related experience in a Technical Services function within the Pharmaceutical industry or a Bachelor’s Degree in chemical engineering or pharmaceutical engineering with minimum of 6 years of directly related experience in a Technical Services function within the Pharmaceutical industry</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Advanced knowledge of the standards and concepts applicable to a wide range of work in pharmaceutical dosage processing including the areas of tech transfer, commercial manufacturing, and unit operations</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Hands on experience in commercial drug product manufacturing/packaging equipment and processes, post-approval change projects and process validation</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Willingness to travel periodically as needed </span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="none">Experience, Knowledge and Skills</span></strong> <span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></p>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Experience with FDA submissions for post-approval change applications</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Detailed knowledge of drug product manufacturing floor activities</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">Experienced with use of statistical software to analyze process related data</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"●","469777815":"multilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="none">Strong hands-on cGMP and FDA regulatory and SOP knowledge</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></li>
</ul>
<p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559685":720,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span><strong><span data-contrast="none">Salary & Benefits</span></strong><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p>
<p><span data-contrast="none">The anticipated salary range for this role is $100,000 - $135,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p>
<p><em><span data-contrast="auto"><span data-ccp-charstyle="normaltextrun">Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.</span></span></em><em><span data-contrast="auto"><span data-ccp-charstyle="eop" data-ccp-charstyle-defn="{"ObjectId":"920dbcde-2834-5e15-a5fa-062170b236ba|1","ClassId":1073872969,"Properties":[469777841,"Century Gothic",469777842,"Century Gothic",469777843,"Century Gothic",469777844,"Century Gothic",469769226,"Century Gothic",268442635,"24",469775450,"eop",201340122,"1",134233614,"true",469778129,"eop",335572020,"1",469778324,"Default Paragraph Font"]}"> </span></span></em><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559738":0,"335559739":0}"> </span></p>
<p><em><span data-contrast="auto"><span data-ccp-charstyle="Emphasis">Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other </span><span data-ccp-charstyle="Emphasis">Axsome team members. </span><span data-ccp-charstyle="Emphasis">Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.</span></span></em><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559738":0,"335559739":0}"> </span></p>
Key Skills
Technical OperationsPharmaceutical ManufacturingProcess ValidationStatistical MethodscGMP ComplianceFDA RegulationsContinuous ImprovementTechnical LeadershipRisk AssessmentData AnalysisChange ControlSOP DevelopmentCollaborationProcess CapabilityTech TransferQuality Assurance
Categories
HealthcareScience & ResearchManagement & LeadershipManufacturingEngineering
Benefits
Annual BonusSignificant EquityGenerous Benefits Package
Apply Now
Please let Axsome Therapeutics know you found this job on InterviewPal. This helps us grow!
Prepare for Your Interview
We scan and aggregate real interview questions reported by candidates across thousands of companies. This role already has a tailored question set waiting for you.
Elevate your application
Generate a resume, cover letter, or prepare with our AI mock interviewer tailored to this job's requirements.