Manager, Pharmaceutical Technology

Validation Rochester, Michigan


Description

Job Summary - a concise overview of the job

 

This position has responsibility for managing activities related to new product commercialization. Responsibilities include managing team activities to ensure successful transfer of new products from R&D into commercial manufacturing as well as technology transfer between third parties and internal manufacturing sites. The incumbent will foster effective cross-functional working relationships with internal and external groups. Experience with formulation and process development of oral solid-dosage, liquid, creams, ointments and other dosage forms is required.  The incumbent will apply innovative manufacturing technology and quality-by-design principles and execute on key projects to achieve business objectives. The incumbent will manage scale-up activities and provide support during process validation and continuous process monitoring for marketed products. The incumbent will support on the floor manufacturing activities, deviation, change control and CAPA, as well as support regulatory submissions. This position requires working closely with Business Development, Research & Development, Manufacturing, Engineering, Regulatory Affairs and Quality Assurance teams. The incumbent is expected to make efficient and effective use of resources, have a well-managed staff, and be an effective collaborator with internal/external customers and supporting departments.

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

§  This position reports to the Senior Director, Pharmaceutical Technology and directly supervises a minimum of 2 direct reports and indirectly leads a minimum of 3 hourly employees.

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Leadership

§  Manages activities for direct reports

§  Partners with R&D and Commercial Operations colleagues to ensure new products are launched on time and ensuring adherence to corporate objectives and goals

§  Provides technical guidance to team members when troubleshooting manufacturing processes

§  Collaborates with formulation scientists and scale-up teams to ensure optimal process development and application of QbD principles

§  Participate in harmonization of business processes across the technical organization implementing best practices accordingly

§  Remain current with regulatory requirements that impact study design, execution, analysis, etc.

§  Stays current with emerging technology within industry

30%

Issue Resolution

§  Communicate with senior management and site leaders to identify and resolve any technical issues.

20%

Financial

§  Accountable for managing technical activities within team to ensure business financial goals are met.

10%

Safety and Compliance

§  Ensures adherence to cGMP’s, standard operating procedures, safety practices and manufacturing protocols. Ensures the safety of all employees through compliance with all company policies, procedures, safety rules, and regulations

§  Accountable for ensuring that standard operating procedures are established and executed in accordance with all regulatory requirements and best practices

10%

Continuous Improvement

§  Participates in Continuous Improvement initiatives, utilizing expert resources to reduce overall cost of goods, manufacturing cycle times, and all forms of waste. Applies Process Excellence methodologies (6 S, Lean Manufacturing, and Six Sigma) to improvement initiatives

10%

Regulatory Compliance

§  Participates in regulatory and internal audits and inspections. Ensures responses to audit observations are made in a timely manner and that appropriate corrective actions are implemented.

10%

Talent Management

§  Responsible for ensuring that training and development plans for staff members are in place to meet future objectives of the business. Participates in Talent Management, succession planning, and talent acquisition.

10%

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

§  Minimum of a Bachelor's degree in Engineering, Life Sciences or related field from accredited university

§  Minimum of 10 years of manufacturing process development experience in regulated environment, with no less than 2 years of supervisory experience.


Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Must possess knowledge of cGMPs and SOPs applicable to position. 21CFR Part 210 and 211 and Part 11

§  Strong knowledge, understanding and demonstrated experience in Supply Chain Operations, including inventory management, planning, scheduling and all associated measures and metrics

§  Knowledge and understanding of pharmaceutical manufacturing, compounding, production processes, and packaging operations, equipment and facilities

§  Knowledge of Standard Work Principles and demonstrate the ability to implement standard work in a visual factory environment

§  Knowledge of statistical and mathematical principles

§  Knowledge and demonstrated application of Process Excellence tools(6S, Visual Factory, Lean Manufacturing and Six Sigma) and methodologies

§  Basic knowledge of computer programs. Background knowledge in pharmaceutical science or engineering is advantageous.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific     e.g. coaching, negotiation, calibration, technical writing etc.

§  Must possess good interpersonal skills,

§  Demonstrate strong collaboration capability

§  Effective verbal and written communication skills

§  Must demonstrate the ability to multi task by performing multiple projects and tasks simultaneously

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  GMP/Manufacturing Environment