Associate Director - Manufacturing Sciences and Technology

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Job description

Associate Director, Biologic MSAT

Job Scope & Purpose:

Our Greater Boston area client is looking for an experienced Associate Director to oversee biologic manufacturing efforts for clinical stage and commercial products The ideal candidate should be well-versed in CMC aspects for development stage and commercial manufacturing programs for biologic compounds. Working cross functionally within manufacturing, Quality and the MSAT team this leader will support tech transfer and product launch with external CMO's including oversight and validation of external vendors

Primary Job Responsibilities:

• Advance MSAT business processes including authoring policy documents and SOPs.
• Support biologic manufacturing through standard setting and technical capability development and deployment.
• Be responsible for tech transfer, event response, authoring process description and maintaining batch record.
• Support process validation to ensure commercial viability in accordance with regulatory requirements.
• -Oversee and ensure the robustness and capability of manufacturing by monitoring of each product's Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) through a continued process verification program and review of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).

Primary Job Requirements:

• Engineering or Life Sciences Education required
• 10+ years Process Development or MSAT experience
• 5+ years in management position in a dynamic, fast growth biotech or pharma preferred
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment.
• Advanced project management experience/skills required including method transfers and risk assessment.
• Ability to gain buy-in from peers within the company and with CMOs, using excellent relationship building and communication skills.
• Knowledge of regulatory, validation and documentation requirements for product development, commercial production and site transfer.
• Proactive, efficient and effective at performing and delegating tasks.
• Some travel to CMO site may be required

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.

PROVEN SCIENTIFIC PLACEMENT™

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.

Code: TechOps

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 or . - provided by Dice