Chemistry Manufacturing Controls

2 weeks ago

Indianapolis, United States Eurofins USA PSS Insourcing Solutions Full time
Job Description

Position Overview:

This position will provide strategic, tactical, and operational direction and support to expedite development of our client’s clinical trial portfolio by helping to develop successful regulatory strategies and submissions in support of clinical trials. 

In order to meet client expectations, it is necessary for our entire PSS team to develop collegial and mutually productive relationships with client GRA-CMC team members and other key stakeholders. 

This position utilizes CMC technical knowledge and regulatory expertise to drive internal consistency and influence effective change management. This team will be expected to influence and execute regulatory strategies that can accelerate the development of assigned project(s).

Job Responsibilities:

Include but are not limited to:

  • Leads preparation, technical and regulatory review, and finalization of CMC sections for global CTA submissions and responds to questions.
  • Takes a proactive leadership role in the critical review of molecule-specific GRA-CMC development strategies and submission content. 
  • Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists.
  • Networks and gains alignment with CMC team members and GRA-CMC regulatory scientists to resolve complex issues.
  • Assists in the development of regulatory strategy and update strategy based upon global regulatory changes
  • Provide high quality, timely and clear regulatory advice to allow CMC teams to make well-informed decisions
  • Evaluate regulatory impact on proposed CMC development plans
  • Anticipates and resolves key technical or operational issues that can impact the function or CMC team.
  • Participates in risk-benefit analysis for regulatory compliance.
  • Develop relationships with GRA-CMC team members that promote open discussion of issues to enable regulatory influence of drug development strategies.
  • Communicates effectively verbally and in writing to influence within GRA-CMC and with CMC development team.
  • Demonstrated negotiation and influence skills. Demonstrated effective teamwork skills, able to adapt to diverse interpersonal styles.
  • Proactively identifies and resolves global CMC regulatory issues.
  • Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies.
  • Partners with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities.

Qualifications

The Ideal Candidate would possess:

  • Five or more years of global regulatory CMC experience, or equivalent experience supporting CMC functions contributing to clinical trial phases of development in various regions, including US, EU, and Asia.  Or 5 years’ experience in large molecule/biologics research and development or formulation

Minimum Qualifications:

  • Bachelor’s Degree in a science discipline (chemistry, biology, biochemistry, or related scientific discipline)
  • Technical knowledge of large molecule/biologics CMC drug development sciences.
  • Pharmaceutical industry experience in CMC technical drug development (drug substance and/or drug product experience in development, commercialization, or manufacturing).

Preferred but Optional:

  • At least 3 years of large molecule/biologics in global regulatory CMC, research and development, or formulation.   
  • Experience in authoring of CTA CMC submission content and responses to questions in various regions, including US, EU, and Asia


Additional Information

 

  • Position is full-time, working Monday-Friday 8:00 a.m.-5:00 p.m
  •  overtime as needed
  • Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply.
  • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
  • #LI-EB1
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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