84 Waterford Drive Marlborough, MA 01752 US
Posted: 11/21/2025 2025-11-21 2025-12-22 Employment Type: Contract Job Category: Manufacturing Job Number: 624089 Is job remote?: Yes Country: United States
20-40 work hours/week
Desired background and experience:
Bachelor's degree in Science/Engineering/Operations or a related field
At least 8+ years of experience in the small molecule DS (API)_manufacturing or development environment
Experience with lifecycle management for commercial products
Knowledge of Good Manufacturing Practices (GMPs)
Requirements:
Support / lead process change activities for small molecule drug substances, intermediates and raw materials as SME
Lead investigations, functioning as SME and resolve discrepancies in a timely manner
Work closely with small molecule DS manufacturing team to understand the capabilities, capacity availability and constraints at the CMOs, develop plans to secure capacity appropriately
Provide technical oversight during GMP manufacturing campaigns
Work closely with Quality Assurance, Regulatory Affairs, Supply Chain, and external manufacturing partners to ensure alignment on timelines and deliverables
Strong technical writing and analytical problem-solving capabilities
Ability to work independently with minimal guidance
Exercise good judgment and make decision that is appropriate for the organization
Results-driven, take initiative and ownership to accomplish work
Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
Must Have’s:
Min 6-8 years experience working in small molecule DS (API) manufacturing as SME in a GMP environment
Has functioned as SME for process changes and investigations
Position is not for those working in diagnostics, cosmetics, biologics, QA, QC, Regulatory, PM
Job functions:
External manufacturing/operations
Drug substance contract manufacturing
Chemical manufacturing
Manufacturing sciences & technology (MSAT)
Chemical or Process Development (but I’m less sanguine about these titles since people in these roles are more early/mid-stage, with less exposure to the business and regulatory aspects of commercial work)
Education:
Min 6-8 years experience working in small molecule DS (API) manufacturing as SME in a GMP environment
Pay ranges between $58-65/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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