Director, Drug Substance

Job#: 2032442

Job Description:

Director of Drug Substance 2032442
Location: Cambridge, MA (Onsite)
Science: Small Molecule Therapeutics
Job Overview:  Oversee the strategy and operations of CMC Drug Substance efforts as the process chemistry SME for programs in clinical development leading to NDA.
Primary Job Responsibilities:

• Lead Drug Substance Tech Transfers while overseeing and managing external CDMO partners for efficiency, quality and deliverables.

• Collaborate with internal teams to ensure proper coordination for DP manufacturing

Primary Job Requirements:

• PhD in Chemistry/ Chemical Engineering or related field with significant experince leading CMC drug substance development

• Experienced at managing external CDMO’s

• Exposure to phase II and III development leading to NDA filing

• Highly adept in the phase appropriate compliance and regulatory aspects of GMP manufacturing

• Willingness and ability to work in a hands-on setting with urgency

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity 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 Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Stratacuity 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. Stratacuity 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.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex 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 our Employee Services Department at [email protected] or 844-463-6178.