Dir, Project Management

Job Description

The Global Quality - Large Molecule Analytical Sciences (GQ-LMAS) team leads the global analytical technical oversight of late-stage pipeline programs through commercialization and launch as well as product lifecycle management support for Large Molecules (Vaccines and Biologics) and Cross-Modality Compounds (e.g. Antibody-Drug Conjugates).

This position will influence life-cycle management of our companys commercial products and include a specific focus on support of local testing requirements for our companys large molecule commercial products in China. The position will involve direct contact with government laboratories and functions in China (for example CDE and NIFDC) in addition to Contract Manufacturing and Contract Testing Organizations. These interactions will include technical discussions and troubleshooting assistance as needed to enable and maintain robust local testing programs in order to ensure uninterrupted supply of our companys biologics and vaccines products in China.

Responsibilities include but are not limited to:

• Establish and maintain an excellent professional relationship with scientists working in Chinas government and contract testing laboratories.

• Support establishment of test methods and provide troubleshooting assistance as needed for testing laboratories and engage additional subject matter experts as needed to assist in resolution of technical issues.

• Facilitate and support logistics activities (for example reagent and sample shipments from to China).

• Lead and/or participate on global cross-functional teams and work effectively with multiple disciplines and personalities to facilitate rapid licensure and approval of commercial product extensions for our companys biologics and vaccines.

• Provide proactive and timely communication of challenges and opportunities to management and help to address them in a systematic and thoughtful manner.

• Influence development of new chapters/sections of regulatory compendia or updates to existing compendial chapters/sections including but not limited to those in the Chinese Pharmacopoeia.

• Coordinate internal company reviews of proposed updates to regulatory compendia.

• Author regulatory and technical documentation supporting regulatory communications as required.

  Participate in verbal and written communications with regulatory agencies.

REQUIRED

Education Minimum Requirement:

• Bachelors Degree (BA/BS) with a concentration in biology chemistry biochemistry or related science with twelve (12) years of relevant industry knowledge working in the field of analytical testing development transfer and/or validation; OR

• Masters Degree (MA/MS) with a concentration in biology chemistry biochemistry or related science with eight (8) years of relevant industry knowledge working in the field of analytical testing development transfer and/or validation; OR

• PhD with a concentration in biology chemistry biochemistry or related science with four (4) years of relevant industry knowledge working in the field of analytical testing development transfer and/or validation.

Required Experience:

• Experience in the biopharmaceutical manufacturing industry such as in biologics or vaccines commercialization technical operations and/or Quality control

• Ability to analyze interpret and troubleshoot analytical data.

• Self-motivated with a positive proactive and service-oriented mindset.

• Demonstrated strong and broad-based scientific technical leadership and troubleshooting skills in the areas of biochemistry molecular/cellular biology and related sciences will be required.

• Familiarity with regulatory-CMC topics and regulatory compendia including but not limited to the Chinese Pharmacopoeia

• Strong organizational and project management skills to handle multiple project associated tasks simultaneously.

• Strong oral and written communication skills to effectively communicate and collaborate with many functional areas.

Preferred:

• Large molecule method development validation and/or transfer experience

• Knowledge of deviation management and change control processes

• QC Laboratory Due Diligence Experience

• Experience with laboratory data management systems (i.e. LIMS)

• Experience with software automation/digital systems (e.g. Veeva Vault MEDs)

Required Skills:

Preferred Skills:

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