Director, CMC - Sterling Pharma Solutions
Sterling Pharma Solutions

Job Info

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Summary of the Role
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.

Your 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 for the role

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

What we offer
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.

Why consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) R&D bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK, US and Europe, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.

Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.

Sterling Pharma Solutions is an equal opportunity employer.
Be caring. Be transparent. Be willing. Be reliable.

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