Seeking Vice President to head the CMC function and ensure scientific, regulatory, and quality standards are followed across process chemistry, analytical chemistry, formulation development, supply chain activities, and manufacturing/commercial production.

The Job:

*** Ensure all development, manufacturing, and process validation activities for drug substances and products are completed in compliance with quality and regulatory expectations for global regulatory submissions.

*** Select vendors and oversee technical management to ensure competence and data integrity through all stages of development.

*** Participate in regulatory CMC strategy development, providing pharmaceutical sciences input to and support for the compilation of regulatory submissions required for clinical trial and marketing applications.

*** Represent CMC in meetings with global regulatory agencies.

*** Prepare and manage complex CMC development plans, budgets, and long-range planning.

*** Provide guidance, mentoring, and development of staff.

Qualifications:

*** PhD in pharmaceutical sciences, chemical engineering, or related scientific discipline.

*** 15+ years of product and process development or commercial manufacturing experience in the pharmaceutical industry for small molecules and solid, oral dosage forms.

*** Leadership experience with a team of CMC development scientists or engineers including process chemists, analytical chemists, formulation scientists, technical operations.

*** Experience in manufacturing process validation, including taking a product through to commercial launch and life-cycle management. Experience with implementation of post-approval changes is preferred.

*** Demonstrated understanding of US, EU, and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use regulations and requirements.

As well as earning six figure salary, candidate is offered full company paid benefits flexible spending account, discount stock purchase plan, tuition assistance, employee assistance program, and company sponsored and paid certification training programs.

For details contact Branden F. Lynch at:
(609) 584-9000 ext 241

Or submit resume online at:
http://dmc9.com/bfl/app.asp

Or email to:
1000028779_10007337@jobbank302.com

Please reference #37527155 when responding.

10 + years

Massachusetts

$200,000.00

$250,000.00

Branden Lynch

609.584.9000 x241

1000028779_10007337@jobbank302.com

http://dmc9.com/bfl/app.asp

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