Associate Principal. Scientist, Chemistry

** Job Description
** Our company is currently seeking an exceptional individual for a technical leadership position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization located at Rahway, NJ, or West Point, PA, USA.  The successful candidate will be joining a group of innovative scientists with broad deliverables ranging from API and Drug Product analytical troubleshooting to drive lead-time reduction and efficiency gains in support of our company’s World Class Supplier and Operationalizing Quality goals.  

The Associate Principal Scientist position is a laboratory-based scientific track role in a fast-paced, multidisciplinary team environment. The incumbent will be expected to influence both internal partners as well as external sites in our Company’s world-wide Manufacturing network in identifying, implementing, and troubleshooting laboratory test methods to ensure robust supply of materials.

The incumbent will:
* Author analytical procedures, development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc.
* Perform investigations with strong technical troubleshooting skills.
* Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity.
* Evaluate analytical methods associated with the critical quality attributes of cGMP materials.
* The individual may also be responsible for technical training of staff, as needed, on analytical techniques and problem solving.
* Possess a strong technical background with excellent problem‑solving skills, solid leadership abilities, strong knowledge of cGMP and Data Integrity are considered essential, as these will be key attributes necessary to facilitate the ability to influence change in efforts to realize Our Company’s World Class Supply vision.
*
* Education Requirements:

*** MS in Chemistry or related discipline with at least 8 years of relevant pharmaceutical development experience or PhD in Analytical Chemistry or related discipline with at least 2 years of experience.
** Required

Experience and Skills:

*** Working knowledge of analytical techniques used in commercial testing of raw materials, intermediates, and drug substances.
* Strong verbal and written communication skills as well as flexibility to work in a dynamic environment (internal and external communications)
* Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures.
* Self-motivated to take ownership and accountability of issues and drive them to completion.
* Ability to quickly adapt to changes and develop appropriate plans for managing risks.
* Advance knowledge of ALCOA+ principles.
** Preferred

Experience and Skills:

*** Advance experience developing various analytical techniques (e.g., chromatography, and spectroscopy) and product specification to support drug substance development and registration.
* Have a fundamental knowledge of synthetic (organic) chemistry.
* Advance experience with API development and commercialization for an analytical perspective.
* Advance experience working with contract manufacture organizations and/or contract research organizations.
* Advance experience working in cross-functional teams.
*
* Required Skills:

** Accountability, Adaptability, Analytical Chemistry, Analytical Development, API Development, Chemical Synthesis, Chromatography, Clinical Judgment, Data Analysis, Data Integrity, Experimental Development, Interdisciplinary Collaboration, Laboratory Techniques, Laboratory Testing, Lead Optimization, Organic Chemistry, Pharmaceutical Development, Professional Networking, Risk Management, Scientific Research, Synthetic Chemistry, Technical Leadership, Technical Training
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and Puerto Rico Residents Only:
** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment…