Manager, CMC Documentation & Specifications

Join our dynamic Chemistry, Manufacturing, and Controls (CMC) Documentation & Specifications team located in Moreton, UK. As a Technical Author, you will be responsible for authoring CMC sections of regulatory submissions and specifications. Leverage your expertise in organic chemistry, biological sciences, biochemistry, or pharmaceutical sciences, alongside your experience in pharma and/or biologics CMC drug substance and/or drug product development, and make a pivotal role in bringing innovative medicines to patients.

Collaborate closely with a range of groups, including Analytical Strategy & Operations, Chemical Process Development, Drug Product Development, Portfolio Strategy & Integration, Manufacturing Science & Technology, Clinical Supply Operations, Nonclinical Safety, and Global Regulatory Sciences. Be part of a team dedicated to advancing groundbreaking therapies and transforming patient lives.

Key Responsibilities

• Compile scientific data to author CMC sections of regulatory submissions for small and large molecules and coordinate filing review activities according to project timelines.
• Lead specification activities for small molecules.
• Assemble and coordinate technical responses to global Health Authorities' inquiries on the CMC sections of regulatory documents.
• Verify data thoroughly to ensure high quality regulatory submissions.
• Proactively identify concerns and provide constructive feedback to the CMC Development Team on potential issues.
• Utilize critical analysis and scientific judgement to address complex problems efficiently and effectively and pay scrupulous attention to detail.

Qualifications & Experience

• Bachelors/Masters degree in organic chemistry, biological sciences, biochemistry, pharmaceutical sciences, or other related scientific discipline with CMC-related pharmaceutical development experience preferred.
• Excellent verbal and written communication skills are essential for effective collaboration.
• Effective interpersonal skills required to foster constructive team interactions and problem solving.
• Familiarity with computer-assisted document preparation tools is highly desirable.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol Myers Squibb is Disability Confident - Employer.