Basic Function and Scope of the Position:
This position directs the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives.
Tasks and Responsibilities:
- To provide both leadership and direction to manufacturing personnel to ensure that products are produced efficiently; that they are of the right quality, quantity, and cost; and that they are produced on time.
- Increases standardization of work processes.
- Continuously improves company’s organizational capabilities to achieve process quality as part of project execution, including an awareness of the need to “do it right the first time.”
- Responsible for continuous improvement of processes, personnel and training in support of cost and performance objectives.
- Work closely with Manufacturing Process Development in the release of new processes or products.
- Selects, develops, and evaluates personnel. Develops business continuity and succession plans.
- Maintains a productive interface with other functional departments.
- Developing and maintaining a “team” environment to ensure the development and retention of personnel.
- Develop budgets and yearly goals for the department. Controls capital expenditures and direct/indirect labor.
- Act as the area subject matter expert for internal and external audits.
- Responsible for area Key Performance Indicators and metric improvement strategies.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Educational Background:
- Requires a minimum BS or MS in Engineering or Sciences
Preferred Experiential Background:
- BS with 8-10 years, or MS with 6-8years related experience in Manufacturing, Mfg. Engineering or Process Development required.
- 5-plus years of production management is strongly preferred.
- Experience with oligonucleotide synthesis, purification and characterization methodologies is desired. Knowledge of nucleic acids chemistry will be a plus.
- Pharmaceutical/life science manufacturing experience is required.
- Experience with cGMP, ISO 13485, or ISO 9001 operations is required.
- Effective communication and interpersonal skills are a must.
- Strong management skills with a proven track record of providing direction and leadership to others are essential.
- Must possess demonstrated skills in leading and managing change.
- Talent Acquisition activities which include identifying needs of the department, justification for budget to fill positions, coordinating with HR to market the position, review resumes, conduct interviews and identify and recommend a candidate as the potential hire, and employee orientation to the department and company.
- Talent Development activities which include developing training plans with employees to ensure they have the necessary expertise to successfully perform their jobs, provide ongoing guidance to employees, and career counseling to help employees develop and advance in their careers
- Job Role Definition ensures that job descriptions accurately record the primary responsibilities, qualifications and terms for each job role in their group
- Performance Management activities include setting performance standards, ensuring employees have appropriate and realistic job goals, providing ongoing feedback about employees’ performance, conducting performance appraisals, including assessing how the employees have performed and how they can improve their performance, developing performance improvement plans if employees’ performance is not adequate and providing rewards for employee accomplishments.
- At higher levels of management, establishing and distributing budgets among departments is required.
- Ensure employees follow all applicable company policies and procedures