CDMO, CMO, Contract Development and Manufacturing Organisation

Director, Manufacturing

Job Title
Director, Manufacturing
Location
Germantown,  WI 53022
Other Location
Description

Summary of Role

The Director Manufacturing is accountable for driving results in a fast-paced environment by developing and up scaling operations at the Germantown, WI API site. The successful candidate will lead and control functions and projects within the manufacturing plant.  The Director Manufacturing provides overall technical leadership to the site and maintains a high level of profitability by ensuring timely completion of projects. 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

  • Manages shift supervisors and Building Manager(s).
  • Maintains good manufacturing practices (GMP) and equipment.
  • Leads staff to monitor and prevent malfunctions of production systems. Ensures equipment readiness and cleanliness, proper function of reactors, transfer lines and computer systems.
  • Provides practical solutions to improve productivity in chemical processing including yields, cycle times and reduction of waste.
  • Ensures clear documentation of all results and procedures.
  • Provides input in development of technical proposals.
  • Participates in investigations and bring problems to resolution.
  • Fosters customer-focused, right-first-time, cost-effective production environment.
  • Ensure site maintains an organized and orderly workflow for operational excellence.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • 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.

Key Competencies

  • Ability to write reports, business correspondence and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients and customers.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form
  • Ability to perform complex math functions, compute ratios, rate, and percent
  • Ability to draw and interpret graphs and charts
  • Demonstrated success and knowledge in work developing and validating analytical methods
  • Previous experience working in a cGMP environment
  • Proven ability to drive metrics and KPI’s
  • Previous experience writing laboratory investigations
  • Directly leads team of approximately 8 - 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.
  • Proficient in MS Office Suite
  • Ability to communicate at all levels both verbally and written
  • 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

  • Bachelor’s degree in Chemistry or Chemical Engineering and 5 years of experience in production and plant management, preferably in an API, contract manufacturing facility.
  • Minimum 10 years related work experience ideally in managing active pharmaceutical ingredient manufacturing operations.
  • Contract manufacturing experience highly desirable.

Physical Demands and Work Environment

The physical demands and work environment 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 regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level is moderate to noisy.  Occasionally, employee may be exposed to airborne particles and fumes.  Occasionally, employee may be exposed to chemicals.  Must have the ability to wear PPE as required.  Employee occasionally may be exposed to moving mechanical parts and vibration.

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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