Discovery Solutions is seeking job seekers for a permanent position with one of our customers, a leading company that has been enriching life by developing innovative solutions that protect and enhance animal health.
LOCATION: Greenfield, IN 46140
DESCRIPTION: The purpose of this Technical Services / Manufacturing Science position is to provide technical support and oversight for established premix and nutritional products managed by the Company-North America organization. A high level of mastery in premix and nutritional manufacturing technologies is required to drive productivity, gross margins, and to ensure a reliable supply of quality products through robust manufacturing processes.
In addition, Company partners with operations/supply chain, quality, launch leaders, and R&D throughout the product life cycle. Company’s role in product support offers a wide variety of technical leadership, project assignments, and work experiences.
Functions, Duties, Tasks:
Provide technical support to contract manufacturers through knowledge of premix and nutritional product manufacturing processes, regulatory requirements, and quality requirements.
Serve as primary technical resource for premix and nutritional manufacturing processes.
Work with cross-functional groups to troubleshoot issues arising at sites, including but not limited to deviations and product remediation activities.
Member of cross functional internal and external process team(s) responsible for the technical stewardship of the process(es)
Maintain an appropriate presence during manufacturing.
Review process and product data for adverse trends; assess and understand process capability.
Identify, evaluate, and implement process improvements/remediation with a focus on capability, compliance, and cost reduction.
Conduct/support process validation/qualifications.
Author Product Quality Reviews.
Develop and maintain manufacturing process flow documents for products.
Understand business needs to determine productivity opportunities for the products supported
Participate in the evaluation of new business opportunities thru due diligence, product reviews, and cost modeling.
Facilitate the Manufacturability Review process.
Lead technical transfer, process implementation, and validation activities as needed.
Support launches in secondary markets, ensuring regulatory commitments are aligned with process capabilities.
EXPERIENCE: 10+ years of relevant pharmaceutical/animal health manufacturing
Preference is for experience in premix and nutritional manufacturing (will consider other industries: pharmaceutical, chemical, food, and possibly medical device).
Understanding of cGMP requirements for drug substance and drug product manufacturing.
Strong problem solving skills, including strategic and creative thinking.
Strong interpersonal skills including flexibility and ability to engage with partners.
Clear, concise communication skills (both written and verbal)
Cross-functional networking skills: demonstrated ability to influence others.
Strong analytical skills.
Ability to handle multiple priorities and deal with ambiguity.
Demonstrated ability to achieve results with people
Knowledge of statistical methods and applicable software.
Understanding of analytical methods.
Working knowledge of Regulus.
Working knowledge of Trackwise.
Ability to manage projects
EDUCATION: Minimum of Bachelors of Science degree with relevant work experience preferably an Advanced Science degree (Engineering, Chemistry, Biology, or Pharmacy)