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Director of Manufacturing Science and Technology

  • LocationBig Flats, NY 14814 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:2 months ago
  • Job no: 42380
  • Category: Production/Manufacturing

Job Description

Our client, a leading pharmaceutical company, is currently recruiting a Director of Manufacturing Science and Technology who will infuse the Manufacturing Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:

1) Support the company's mission and vision statement by adhering to the code of corporate values and conforming to established performance expectations

2) Assist in the selection of new personnel as appropriate

3) Make provisions for the proper orientation and training of new personnel

4) Review employee performance on a regularly scheduled basis

5) Develop recommendations for employee career planning and development and oversee the process for individual skills assessment and continuing education plans

6) Coach and direct personnel to ensure compliance with departmental goals, objectives and budgets

7) Conduct regular meetings and provides guidance and direction to personnel

8) Review employee’s time records, makes any necessary corrections, obtain appropriate signatures and submit for payroll processing

9) Organize, schedule, prioritize and distribute workload among assigned personnel

10) Keep personnel informed of pertinent policies and procedures affecting the department and/or their jobs

11) Create an atmosphere in which upward communication from employees is encouraged

12) Administer personnel policies and procedures as established by company policy

13) Manage cost center expenses as follows

14) Construct a budget within prescribed guidelines

15) Manage expenses to stay within budget; request and approves payments depending on the level of authority

16) Review expenses on a regular basis to ensure proper recording of account expenses

17) Explain variances, exceptions and other impacts that occur between budget and actual expenses

18) Grow the CMO MSAT function by establishing clear team identity, roles and responsibilities and hand-offs with other functions

19) Drive understanding of technical requirements and expectations at CMOs in anticipation of robust regulatory requirements in product and process development, including data integrity

20) Partner with internal and external teams to support the product development pathway of mid to late-stage development programs, which require CMO services to meet very specific development goals

21) Provide routine technical support of the CMOS for deviation management, lot disposition and batch record reviews through joint CMO Project Management teams

22) Provide technical support for tech transfers between CMO sites

23) Review and support all analytical testing methods and processes and offers support in the establishment of product specifications to ensure complete alignment with commercial product definition

24) Designs process optimization activities to ensure manufacturing processes are robust and cost-effective

25) Direct Quality-by-Design work for drug product manufacturing

26) Review and provide oversight of all documentation related to the production of the drug products including development, scale-up and validation protocols/reports, batch records, deviations, process excursions, SOPs, etc.

27) Interfaces with and provides direction and management of the company's CMOS to ensure drug product operations are conducted in compliance with cGMP requirements

28) Reviews chemistry, manufacturing and control (CMC) sections of regulatory documents working in collaboration with Regulatory, to ensure the accuracy and comprehension of every filing consistent with development history and manufacturing requirements

29) Support the CMO selection process by evaluating CMO/supplier technical capabilities against applicable manufacturing, quality and compliance requirements, in collaboration with the Business Development function

30) Ensures that CMC life cycle strategies for products are implemented at CMOs and support regulatory submissions and approvals

31) Develop risk-based strategies for the CMO technical oversight

32) Work directly with third-party development partners to establish robust and effective development strategies to align with successful launch requirements

33) Recruits top talent and develops the staff within any future MS&T-related roles

34) creates a performance-based culture through accountability, coaching and mentoring of staff

35) Establishes a robust coaching/training program for team members on communicating effectively both written and verbally on the strategies to senior management.

36) Champion and enhance the standard best practices in program and portfolio management

37) Attend technical and management meetings and schedule work to align with department objectives

25) Ensures compliance with government rules and regulations

26) Performs other related duties as assigned or directed

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the pharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in manufacturing

For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience

  • Published on 11 Aug 2022, 9:00 AM