Associate Director Analytical Development - Drug Product
Princeton, NJ 
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Job Description

For the safety of our employees and communities in response to COVID-19, Acadia has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.

Position Summary:

Responsible for oversight of the outsourced analytical development activities associated with the method development, validation, and technology transfer of drug product. Manages multiple contract service providers (CSPs) to deliver comprehensive, consistent, and compliant analytical results.

Primary Responsibilities:

  • Develops and validates analytical methods for small molecules in various dosage forms:
    • Participates with others to plan analytical development and testing requirements
    • Collaborates with testing labs to develop analytical methods
    • Drafts and/or reviews method validation protocols and reports
    • Drafts and/or approves analytical methods
    • Provides information for chemistry, manufacturing and control (CMC) section of regulatory documentation
  • Provides oversight of testing at contract service providers (CSPs):
    • Reviews testing sections of process development protocols and reports
    • Reviews analytical raw data
    • Define testing requirements
    • Observes, as needed, testing at CSPs
    • Travels to site to assess technical abilities and for formal planning activities
  • Liaises with manufacturing, quality and regulatory counterparts to develop plans and protocols for drug product development
  • Performs laboratory investigations:
    • Investigates and/or reviews CSP out-of-specification/out-of-trend (OOS/OOT) for scientific soundness and completeness.
    • Assesses performance of CSP laboratory for accuracy and technical expertise.

Education/Experience/Skills:

M.S. in Chemistry or related field. Ph.D. preferred. An equivalent combination of relevant education and applicable job experience may be considered. A minimum of 7 years' experience in progressively responsible roles with a focus on analytical development techniques for finished drug products with 3 years' in a leadership role required.

Experience authoring technical reports and CMC sections for regulatory filings. Related experience should include hands on experience in at least one of the following analytical chemistry techniques - chromatography, dissolution and/or spectroscopic techniques. Experience with oversight management of CSP analytical laboratory preferred.

Must possess:

  • Strong understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH guidances, 21 CFR Part 211, 21 CFR Part 11)
  • Working knowledge of United States Pharmacopeia (USP) and European Pharmacopeia (EP)
  • Demonstrated problem solving abilities
  • Strong organizational and documentation skills
  • Demonstrated verbal and written communication skills
  • Ability to manage change in a dynamic environment
  • Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization
  • Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals
  • Ability to travel up to 15% of the time both domestically and internationally (with COVID parameters)

Scope:

Provides direction to and review of, managers, supervisors, or employees in a segment of a functional area and/or manages segment to achieve goals in accordance with established policies, meet schedules and resolve problems. Develops, modifies, and implements policies that affect immediate operations and may also affect overall functional area. Works on abstract problems that may cross functional areas. Identifies and evaluates fundamental issues for functional area through assessment of intangible variables. Contributes to the planning of, and implements, department budget. Regularly interacts with senior management and executives on matters concerning functional area, division and/or customers. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations. Erroneous decisions will have a serious impact on the overall success of functional area and may impact overall company operations.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.

Acadia is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity

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Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
7+ years
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