Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

TWO New Administrative Positions -

A. Director, Quality Control

We are seeking a highly motivated and energetic Director to lead the Momenta Quality Control team. The successful candidate will be responsible for planning, coordinating, and managing all Quality Control activities, as well as oversight of testing at contract laboratories, including associated technology transfer and validation activities, for our portfolio of development and commercial products.

The Director of Quality Control will be responsible for management of the QC function, including short-term and long-term resource planning. He or she will work closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements and will conduct briefings and technical meetings for internal and external representatives including equivalent or above management. This position will represent Momenta QC to both internal and external organizations, including CMO/CROs and Momenta partners.


Requirements:

PhD in a scientific discipline and a minimum of 8 years experience in an analytical development and/or Quality Control environment; MS with 10+ years experience, or; exceptional BS candidates with 15+ years experience.

Strong knowledge of cGMP principles as applied to quality control laboratories

Demonstrated leadership and management skills

Experience in technology transfer and management of contract testing laboratories.

Excellent communication skills including the ability to write technical reports and CMC sections for regulatory submissions

Ability to work in a fast-paced, dynamic, environment.


B. Director, Drug Product Development and Manufacturing


We are seeking a highly motivated and energetic Director to lead the Momenta Drug Product Development team. The successful candidate will be responsible for planning, coordinating, and managing the formulation and drug product process development activities, as well as oversight of parenteral drug product manufacturing at contract manufacturers, including associated scale-up, process optimization, technology transfer, and/or validation activities.


The Director of Drug Product Development will be responsible for management of the drug product development function, including resource planning and development of an internal laboratory capability. He or she will work closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements and will conduct briefings and technical meetings for internal and external representatives including equivalent or above management. This position will represent Momenta drug product development to both internal and external organizations, including CMO/CROs and Momenta partners.


Requirements:

PhD in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 years experience in a development environment.

Demonstrated leadership and management skills

Experience in drug substance and drug product protein formulation, including lyophilization 1

Experience in cGMP, aseptic manufacturing of parenteral drug products.

Experience in technology transfer and management of contract manufacturers.

Firm understanding of drug delivery options

Excellent communication skills including the ability to write technical reports and CMC sections for regulatory submissions

Ability to work in a fast-paced, dynamic, environment.

1 LYOPHILIZATION or FREEZE DRYING - Pharmaceutical companies often use freeze-drying to increase the shelf life of the products, such as vaccines and other injectables. By removing the water from the material and sealing the material in a vial, the material can be easily stored, shipped, and later reconstituted to its original form for injection. Another example from the pharmaceutical industry is the use of freeze drying to produce tablets or wafers, the advantage of which is less excipient as well as a rapidly absorbed and easily administered dosage form.

http://www.momentapharma.com/careers/search-current-openings.php