CDMO, CMO, Contract Development and Manufacturing Organisation

Technical Manager

Job Title
Technical Manager
Location
Germantown,  WI 53022
Other Location
Description

Summary of Role
The Technical Manager is accountable for driving results in a fast-paced environment by directing all product development team activities.  The Technical Manager is responsible for coordinating the direction of the development program (Chemistry, Analytics, Engineering and Solid State Chemistry) through development and production.  The Manager directs and develops the technical control strategy with the team and ensures appropriate communication and partnership with the key stakeholders external to the work cell (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 Project Manager and is responsible for the collaborative development and performance of the work cell team members.  The Manager ensures a high level of execution during development and manufacturing phases of the program, in alignment with the deliverables in the contract, and a high level of intrinsic value addition to the product.  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

  • Responsible for managing the direction of the CMC strategy of new API product development programs with their cross-functional scientific team (Chemistry Development, Analytical Development and Process Engineering) through design, optimization and into production.
  • The Manager directs and develops the process design and development plan with the team and ensures appropriate communication and partnership with the key stakeholders external to the 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 Project Manager and is responsible for the collaborative development and performance of the development team members.
  • The Manager ensures a high level of execution during development and manufacturing phases of the program, in alignment with the deliverables in the contract, and with a high level of intrinsic value addition to the product and process.
  • Leads the team through execution of the required process and analytical development to ensure a right-first-time synthetic process control strategy is created and implemented into production.
  • Works collaboratively with the other new product development teams to improve best practices and technical acumen across the Science and Technology organization.
  • Responsible for the scientific substance of projects, ensuring accountability of team members to standard work deliverables as well as their integration with the other development functions
  • Embraces and develops a culture of innovation to add value to the customer’s program and increase technical excellence at the site.
  • Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training, and development, coaching and mentoring, and performance management.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • 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.

Education and Experience

  • 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.

Key Competencies

  • Functional knowledge of project management, process chemistry, GMP and EHS guidelines.
  • Able to independently judge the scientific aspects of the chemistry of, and solve the problems in, projects, and able to prepare and lead a work plan.
  • Capable of leading (small) project teams.
  • Has understanding of the mechanism of operation of the organization and effective planning of projects and production campaigns.
  • Able to work with employees at all levels within the organization.
  • Strong written and oral communication and presentation skills.
  • Directly leads team of approximately 7 - 10 direct reports.
  • Participates in the hiring process of other employees.
  • Makes hiring decisions of other employees.
  • Schedules and reviews the work of other employees.
  • Ensures accuracy and relevance of assigned training curriculum.
  • Drives timely completion of training for employees to meet regulatory requirements.
  • Coaches, mentors and develops other employees.
  • Prepares and delivers performance evaluations of other employees.
  • Makes recommendation of disciplinary actions of other employees.
  • Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel.
  • 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. 

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 organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 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. 

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