Manager, Process Chemistry in Irvine, CA

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Matthew Masterson
Matthew Masterson's picture
Manager, Process Chemistry in Irvine, CA

 Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life?s potential. Today, we have 11,000+ employees highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

The Process Chemistry group (Prochem) is responsible for supply of small molecule, drug substance for all phases of Allergan?s research and development activities. This includes Medchem/Discovery support, sample synthesis, early development chemistry, process research, scale-up and process validation. These synthetic chemistry projects are done entirely by outsourcing with various contract research or manufacturing organizations (CRO/CMO). Prochem is responsible for providing quality assurance and global CMC regulatory guidance to CRO/CMO?s. Prochem group employees may participate on Allergan development teams, contribute to global development plans, and prepare drug substance sections for regulatory submissions. Prochem group employees practice and administer adherence to Allergan import/export compliance policies and occupational safety and fire safety policies, both within Allergan Discovery Research and with our external CRO/CMO?s.

Requirements include:

Synthetic Chemistry. Independently provides technical input on multiple projects related to:

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Preparation of chemistry technical data packages for CMO?s.

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Review of synthetic chemistry reports, process development activities, and manufacturing data from vendors.

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Support and management of small molecule, technical projects from other functions (PharmSci, Biological Sciences, Bioanalytical, etc.).

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Assist Medchem with outsourcing support and technical advice

Chemistry Contract Project Management. Independently provides oversight and responsibility for multiple projects related to:

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Selection of appropriate CMO/CRO for project/phase specific activities

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Negotiation of quotations and preparation of Work Orders

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Review and active management of synthetic chemistry activities at CRO/CMO?s

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Review and active management of analytical chemistry activities at CRO/CMO?s

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Review and active management of process validation activities at CRO/CMO?s

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GMP compliance activities

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Project/Budget planning

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Under supervision provides planning activities across projects.

Requirements: 
Education and Experience:

Ph.D. + 4 years specific experience in a chemistry related field in the pharmaceutical or API manufacturing industry; MS +7 years specific experience in a chemistry related field in the pharmaceutical or API manufacturing industry; or BS + 9 years specific experience in a chemistry related field in the pharmaceutical or API manufacturing industry. Ph.D. strongly preferred. Must be willing to travel up to 20%.

Essential Skills and Abilities:

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Knowledge of synthetic chemistry is preferred.

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Excellent communication and negotiation skills

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Knowledge of CGMP is required

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Knowledge of worldwide API CMC regulatory requirements is desired.

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Attention to detail

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Excellent internal and external follow-up
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