Job Title: Director CMC

Location: Germantown, WI On-site

Duration: Full Time

As the Chemistry, Manufacturing and Controls Director, you are working with Development, Commercial, Quality and Operational organizations to ensure there is a cogent approach to preclinical and clinical drug development, and the subsequent commercialization.

This includes the chemistry, manufacturing and analytical controls developed to support client IND (investigational new drug application), NDA filing, and commercialization of production of drug substances.

The Director will be expected to assist in and lead the discussion on the best approach to meet the needs of the client and of Sterling for new drug development.

Responsibilities

Serves as a liaison between Manufacturing, Business Development, Technical Evaluations, Quality and R&D teams.

Ensures the technical organization is following the technical governance process and has instituted an appropriate control strategy to meet the product needs based on clinical or commercial phase.

Identifies potential opportunities (filing and process upgrades) and risks with CMC gaps in existing portfolio and devises strategies to address.

Identifies critical path/activities, risks, contingencies and alternatives to improve the efficiency of the groups.

Prepares and carries out presentations related to projects to internal and external audiences.

Participates in investigations and providing technical knowledge where applicable or requested.

Provides input and strategy in the development of technical proposals.

Acts as a technical consultant to R&D groups in streamlining timelines to begin manufacturing.

Provides strategic insight for new business and technology opportunities.

Leads junior members of the CMC team, production engineering, and technical writers

Embodying our company values, which are: be reliable, be caring, be transparent and be willing.

Requirements

Master’s or Doctoral degree in Chemistry or related field with a minimum of 10+ years of related experience, including technical leadership.

Job Type: Full-time

Pay: $90,000.00 - $120,000.00 per year

Benefits:

• 401(k)

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person

Speak with the employer
+91 7325540878

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