CDMO, CMO, Contract Development and Manufacturing Organisation

Director, CMC

Job Title
Director, CMC
Location
Germantown,  WI 53022
Other Location
Description
Summary of Role
The Chemistry, Manufacturing and Controls Director is accountable for driving strategy and results in a fast-paced environment by 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.  This will include being a key liaison with the customer and the internal technical organization.  The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions
  • 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
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.  Serve as a consultant to the customers on their filing strategies and documentation.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
Key competencies
  • Current working knowledge of cGMP and related compliance regulations and guidance is required.
  • Ability to address project challenges by collaborating with internal and external teams.
  • Ability to develop appropriate control strategies to rapidly progress new drugs into and through the clinical as well as successfully commercialize.
  • Self-starting, motivated person who possesses strong interpersonal skills and is able to navigate the intricacies and tight timelines within a CDMO while managing messaging to clients.
  • Proven ability to be an effective hands-on leader.
  • Must have excellent organizational and technical documentation skills.
  • Excellent verbal and written communication skills as well as presentation skills required.
  • Accountable for leading and influencing others.
  • Participates in the hiring process of other employees.
  • Coaches, mentors and develops other employees Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. 
  • Duties, responsibilities and activities may change at any time with or without notice. 
Education and Experience
  • Master’s or Doctoral degree in Chemistry or related field with a minimum of 10+ years of related experience, including technical leadership.
Travel Requirement
  • Up to 10% travel required
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently walk; talk or hear; and use hands to finger, handle or feel.   The employee is required some of the time to stand and sit.  The employee is required to occasionally climb or balance; stoop, kneel, crouch or crawl; reach with hands and arms. The employee must some of the time lift and/or move up to 10 pounds.  There is no special vision requirement for this job. 

Diversity and Inclusion
Sterling values diversity and we are committed to creating an inclusive environment for all employees.  All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
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