Senior Manager of Analytical Development

Proclinical is seeking a Senior Manager of Analytical Development for an innovative pharmaceutical company located in New York City.

As the Senior Manager of Analytical Development, you will manage and coordinate analytical activities on multiple early and/or late phase clinical development programs.

The ideal candidate will be a team player comfortable working on a small team in a fast-paced environment and with contract manufacturing and development organizations.

Must be eligible to work in the US.

Job Responsibilities:

• Work closely with the CMC team (and specifically the head of analytical development) to manage and coordinate analytical activities on multiple early phase drug substance and drug product small molecule solid oral formulation programs.
• Manage early and/or late phase drug substance and drug product analytical activities at contract development laboratories (method development, method qualifications/validations, method transfers, analytical investigations support).
• Review and/or author analytical technical/development and method qualification/validation reports and raw data as well as release and stability data packages.
• Authoring of CMC sections of regulatory submissions.
• Manage drug substance and drug product stability programs (QC and technical review of stability data packages, including stability data trending).
• Assist in the development of analytical development related policies and standard operating procedures.
• Manage reference materials and reference standards inventory and (re)qualification testing.
• Additional responsibilities as assigned.

Skills and Requirements:

• Bachelor's degree in Analytical Chemistry or Chemistry or related field with 7+ years or MS/PhD with 5+ years of GMP and GLP-related pharmaceutical industry experience in small molecule solid oral formulation analytical.
• Knowledge of drug product solid oral dose formulations.
• Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF, MS, dissolution, spectroscopy, and particle size.
• Functional understanding of small molecule analytical development and associated regulatory and quality requirements.
• In-depth understanding of GMPs and applicable CMC, analytical and manufacturing regulatory.
• Working knowledge of pharmacokinetics and drug metabolism not required but beneficial.
• Demonstrated experience in managing outsourced analytical activities.
• Demonstrated experience in QC data review of release and stability data packages for both drug substance and drug product.
• Experience working on commercial stage products highly valued.
• Excellent verbal and written communication skills.
• Excellent problem solving and interpersonal skills.
• Exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities.
• Ability to work in a cross-functional team environment and to be a team player as well as the ability to work independently.
• Flexibility to accommodate multiple time zones as needed.
• Preference to energetic candidates with a desire to think "outside the box".
• Willingness to travel periodically as needed.

If you are having difficulty in applying or if you have any questions, please contact Sam Jankura at +(1) 617-671-0335 or s.jankura@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-SJ1

INDSCIC