Research Scientist- Injectable Product Manufacturing Support

Compensation

: $90,945.00 - $166,990.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



Loading some great jobs for you...





Research Scientist Injectable Product Manufacturing Support

COMPANY:

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 injectable and liquid products managed by the Company - North America organization.A high level of mastery in injectable and liquid manufacturing technologies is required to drive productivity, gross margins, and to ensure a reliable supply of quality products through robust manufacturing processes.

In addition, this research science group partners with Company operations/supply chain, quality, launch leaders, and R&D throughout the product life cycle.The research scientist 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 injectable and liquid product manufacturing processes, regulatory requirements, and quality requirements.

Serve as primary technical resource for injectable and liquid 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:

5+ years of relevant pharmaceutical/animal health manufacturing experience in injectable and liquid manufacturing

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.

Computer literacy.

Demonstrated ability to achieve results with people

Scientific curiosity

EDUCATION:

Minimum of a Bachelors of Science degree preferably an Advanced Science degree (Engineering, Chemistry, Biology, or Pharmacy) or PhD



Job Requirements:
  • The purpose of this Technical Services / Manufacturing Science position is to provide technical support and oversight for established injectable and liquid products managed by the Company - North America organization. A high level of mastery in injectable and liquid manufacturing technologies is required to drive productivity, gross margins, and to ensure a reliable supply of quality products through robust manufacturing processes.

    In addition, this research science group partners with Company operations/supply chain, quality, launch leaders, and R&D throughout the product life cycle. The research scientist 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 injectable and liquid product manufacturing processes, regulatory requirements, and quality requirements.

    Serve as primary technical resource for injectable and liquid 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.s

Associated topics: aseptic, bacteria, biopharmaceutical, dietary, disease, healthcare, histotechnologist, immunoassay, medical, pharmacy * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

Launch your career - Create your profile now!

Create your Profile

Loading some great jobs for you...