Qualifications:

Candidates with a Master’s or PhD degree in Pharmacy or Engineering with minimum of 10 years of directly related experience in a Technical Services function within the Pharmaceutical industry.

Requires advanced knowledge of the standards and concepts applicable to a wide range of work in pharmaceutical dosage processing including the areas of formulation development, tech transfer, commercial manufacturing, and unit operations.

Detailed knowledge of drug product process validation and cleaning validation.

Experienced with use of statistical software to design DOEs and analyze process related data.

Able to perform project management and drive for results through collaboration with internal & external partners.

Strong hands-on cGMP and FDA regulatory knowledge.

Able to travel up to 25% of the time.

Candidates with ophthalmic and injectable experiences will be preferred.

Responsibilities:

You will provide technical leadership for drug product tech transfer activities to enable successful commercial product launches.

This includes participating in development teams for late phase assets, commercial site selection, design and evaluate tech transfer studies, generation and execution of process performance qualification (PPQ) studies, and writing/reviewing important sections of regulatory dossiers.

Work with the drug product team and manufacturing site technical leads to develop and communicate a tech transfer plan.

Lead or advise on equipment and process validation activities.

Ensure a high level of current technical knowledge is maintained within the development team.

Provide on-site support for tech transfer activities when needed.

Collaborate with Sourcing department for selection of raw materials and components when needed.

As needed, lead or support significant technical investigations at other manufacturing sites.

Designs complex technical projects or investigations, interprets diverse data and results, and able to recommends next steps.

Lead multiple projects of moderate or high complexity within or across departments, and lead complex multi-site/function investigations if applicable.

Play a significant role in continuous improvement efforts.

Provide leadership support and technical consultation to other functions within the company.

Prepare and review technical transfer documents, validation protocols and reports.