Part-Time Pharmaceutical Manufacturing Manager
Location: Remote (Must have access to a major airport)
About Us:
Atlantic Management Resources has partnered with a dynamic mid-sized pharmaceutical company known for its great corporate culture. This company licenses and develops several innovative products across various therapeutic classes. They are now seeking an experienced Pharmaceutical Manufacturing Manager to join their team on a part-time basis.
Position Overview:
We are looking for a skilled and dedicated Part-Time Pharmaceutical Manufacturing Manager to evaluate, assess, and support the qualification of new API and drug product manufacturing and testing sites. The ideal candidate will have a strong background in pharmaceutical manufacturing, regulatory support, and working with contract manufacturing partners.
Key Responsibilities:
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Evaluate and support the qualification of new API and drug product manufacturing sites, both for commercial brands and product development candidates.
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Manage the company’s global contract manufacturing partners, including batch processing, procurement of raw materials, and addressing quality issues.
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Oversee the transfer of manufacturing for current brands to new sites as needed and manage the scale-up and qualification of manufacturing for new products.
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Write the manufacturing sections and provide support for the preparation and review of regulatory CMC submissions, including Agency Meeting Packages, INDs, NDAs, ANDAs,
amendments, supplements, and responses to requests for information. -
Serve as a manufacturing operations representative on internal and external product teams.
Qualifications:
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5+ years of relevant pharmaceutical or bio-pharmaceutical experience.
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Bachelor’s degree in Biology, Chemistry, Microbiology, Pharmacy, or related engineering subjects.
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Experience with CMC filings, including INDs and NDAs.
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Knowledge of FDA, ICH, and other relevant CMC, Quality, and cGMP guidance documents.
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Strong experience in reviewing manufacturing records, regulatory documents, and supporting the preparation of scientific and regulatory submissions.
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Familiarity with the regulatory and scientific challenges associated with drug development and manufacturing.
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Desire to work part-time (20 hours per week).
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Must live in the U.S. with access to a major airport.
What We Offer:
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Competitive salary of $50,000 per year (for 20 hours per week).
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Annual bonus of $7,500, based on performance.
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Equity in the company.
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A flexible, remote working environment with a supportive corporate culture.
If you are an experienced Pharmaceutical Manufacturing Manager looking for a flexible part-time role in a rewarding environment, we’d love to hear from you!