Commercial Technical Manager

Location: Germantown, Wisconsin, US
Department: Research and Development
Reference: VN645
Summary of the role
As the Technical Manager, Commercial Products, you are directing commercial product support activities.  The Technical Manager is responsible for coordinating the direction of process performance monitoring and identifying and leading process improvements.  The Technical Manager directs their team on the execution and gaps associated with the control strategy, process design, and unit operation and equipment support while ensuring appropriate communication and partnership with the key stakeholders external to the technical team (e.g., production, EH&S, QC, and QA).  The incumbent will play a key role in external communication with the customer in support of the Partnership Manager and is responsible for the collaborative development and performance of the technical team members.  The Manager ensures a high level of execution during the manufacturing phase of the program, in alignment with the deliverables in the contract, and providing a high level of intrinsic value addition to the product.  

Your responsibilities
  • Leads planning and technical support for execution of commercial product production.
  • Ensures that the product documentation and deliverables are kept up-to-date with the relevant data pertaining to regulatory status, process performance, supply chain and production activities.
  • Is responsible for the scientific substance of processes, ensuring accountability of team members to functional standard work deliverables as well as their integration with other technical functions.
  • Embraces and develops a culture of innovation for the purpose of adding value to the commercial portfolio.
  • Owns the change management process for the introduction of process improvements and gap remediation on the commercial product portfolio.
  • Leads the technical team in execution of investigations, continuous process verification protocols, reports, and reviews.
  • Works closely with the manufacturing organization to identify improvements and provide support from the production engineering and support chemistry teams.
  • Leads technical initiatives cross-functionally to improve the right-first-time execution of production campaigns; identifying and reducing sources of variation and risk.
  • Works closely with Regulatory and CMC functions to evaluate potential impact of proposed changes.
  • Coordinates the generation of updates, reports, protocols and governance packages, ensuring scientific and executional accuracy.
  • Leads technical writing team in the planning and execution of quality document (e.g. Master Production Record) creation and associated template creation, updates, and templates to drive consistency, quality and executability.
  • Ensures readiness of development outputs (materials, technical documents and work plans) and drives deliverables with the team for manufacturing readiness (STR’s, MPR’s, MACO’s, materials, methods, etc.).
  • Ensures that production campaigns (if required) are supervised by the technical team.
  • Is the primary contact for customers and auditors concerning the scientific aspects of products.
  • Contributes to project technical evaluations for the purpose of product costing evaluation for commercial supply agreements.
  • Directly leads team of approximately 3 - 7 direct reports.
  • Embodying our company values, which are: be reliable, be caring, be transparent and be willing.
Requirements for the role
  • Bachelor’s Degree (Chemistry, Pharmaceutical Sciences, Engineering, or related) required.
  • Master’s or Doctorate Degree preferred.
  • 5-7 years of related experience required; 12+ years preferred.
  • Prior pharmaceutical experience required; prior CDMO experience preferred.
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.

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.

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