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Senior Scientist/Manager Process Chemistry/Drug Substance 993293

Location
Burlington, MA, United States

Posted on
Aug 12,2019

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Job Scope & Purpose: Our Greater Boston area client is seeking a Senior/Lead Scientist/Manager to manage drug substance development and manufacturing for several critical programs at various stages in their lifecycle. The ideal candidate will be well versed in process development for drug substance of solid oral dosage forms and will manage multiple external vendors producing API. Primary Job Responsibilities: Managing drug substance development and manufacturing at CDMO’s for multiple programs Sourcing of starting materials for drug substance manufacturing and ensuring their timely delivery and quality Provide technical review of the batch records, and work with Quality Assurance personnel on review of batch records, deviations and CAPA’s to ensure GMP Manufacturing compliance Planning stage-appropriate development activities, and working with the CRO/CDMO’s on their timely execution Authoring of drug substance IND/IMPD/NDA sections as needed Manage drug substance-related documentation, batch records, development reports, and stability reports by following internal SOP’s Coordinate periodic meetings with CRO’s/CDMO’s to monitor the progress of ongoing work, and provide technical feedback, review reports and meeting minutes Primary Job Requirements: Ph.D. in Organic Chemistry with 5 years of Process chemistry experience in biotech, pharma or CDMO industries, or MS with at least 10 years industry experience Familiarity with cGMP and ICH guidelines for drug substance Experience with managing CDMO’s Experience with process development for drug substance, scale-up, and process transfer between CRO’s/CDMO’s Experience with analytical method development and validation for drug substance and starting materials Experience with technical report writing? About **MEMBERS ONLY**SIGN UP NOW***.: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each **MEMBERS ONLY**SIGN UP NOW***. team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a **MEMBERS ONLY**SIGN UP NOW***. team member to discuss your career goals. We will not share your information with anyone without your direct prior consent. PROVEN SCIENTIFIC PLACEMENT™ **MEMBERS ONLY**SIGN UP NOW***. is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. **MEMBERS ONLY**SIGN UP NOW***. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.,

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