Apex Systems

Job#: 2013639

Job Description:

Manager/Senior Manager, CMC, Drug Product 2013639

Location: Boston, MA (Hybrid)

Therapeutic Areas: Undisclosed

Job Overview: Seeking a Manager/Senior Manager CMC to oversee the outsourced process development and cGMP manufacturing campaigns for Drug Product of small molecule drug development programs.

Primary Job Responsibilities:

• Lead and manage multiple concurrent CMC Drug Product projects at CDMOs, including formulation development, process optimization and validation, cGMP manufacturing campaigns, and scale-ups and technology transfer.
• Oversee process scale-up activities to meet forecasted commercial demand as programs progress through development.
• Collaborate with internal and external teams to research, develop, and test processes, analytical methods, and controls for drug product development, and recommend and select vendors for relevant projects.

Primary Job Requirements:

• PhD or MS in Chemistry, Pharmaceutical Sciences, or Chemical Engineering.
• Possess a minimum of 5 years’ experience in the pharmaceutical industry, with a focus on formulation, process development, and cGMP manufacturing of solid oral dosage drug product.
• Demonstrate experience and proficiency in working, collaborating with, and managing CDMOs.
• Strong understanding of solid oral dosage process technologies and a comprehensive knowledge of cGMP for drug product manufacturing
• Good understanding of cGMP drug product manufacturing guidelines under US and EU regulatory agencies
• Previous experience with writing and supporting CMC regulatory submissions including IND and CTA

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.

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 employeeservices@apexsystems.com or 844-463-6178.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.