Job Description

The Company

Our client is a global pharmaceutical company that develops, manufactures, markets, and sells various pharmaceutical products worldwide.

Purpose of the Position

Reporting to the Site General Manager, the Director will oversee the establishment, implementation, maintenance, and sterilization of production equipment and facilities at the company’s Midwest US - based aseptic facility. These responsibilities include but are not limited to raw material sampling, dispensing, product formulation, and aseptic/sterile primary packaging of products in plastic bottles, vials or syringes with oversight for inspection, secondary labelling, and packaging of the finished product.

He/she will oversee the execution of commercial production and support developmental and technical transfer production activities across three shifts. Our client is looking for a hands-on, operational change agent that can foster innovation and better continuous improvement practices.

The ideal candidate will bring proven team leadership and experience in managing manufacturing site filling operations with diverse pharmaceutical and sterile injectable products at similar scope/scale. This individual will live within commuting distance to the site (Midwestern US) and/or be open to relocation (assistance provided), with the ability to be onsite ~4-5 days per week.

Key Responsibilities

Operations and Compliance :

• Oversees execution of commercial production to meet patient, quality, business, and financial objectives as well as supporting developmental and technical transfer production activities across three shifts.
• Directs production in Sanitation, Preparation Services, Drug & Chemical Dispensing, Bulk Manufacturing, Sterile Filling, Inspection & Packaging.
• Establishes and drives expectations for production schedules & reducing non-value-added waste while meeting weekly delivery schedule and financial objectives
• Sets priorities to meet internal cycle times and delivery schedules. Maintains proper staffing and training levels to meet requirements.
• Develops and maintains a safe manufacturing environment in accordance with plant and corporate policies in addition to local, state, and federal EHS regulations. Participates in safety meetings, investigates accidents, ensures proper PPE and industrial hygiene controls, and takes appropriate corrective actions to eliminate hazardous conditions.
• Performs site performance assessments and risk assessments based on business development and new product/process/technical transfer activities associated with employee operations, GMP Compliance, and safety.
• Directs change controls related to processes, equipment, documentation and safety practices in accordance with Quality System requirements.
• Manage audits and inspections by regulators, corporate office and contract customers by escorting and facilitating information sharing, document review and response commitments. Assures cGMP compliance with regulatory agencies (FDA, EMA, etc.)
• Lead initiatives for root cause analysis to implement effective corrective actions, reducing the potential for deviations related to human error.

Budgetary Management & Delivery Performance:

• Oversight for 5 budgetary departments representing 7n operational working units 1) Sanitation, Drug & Chemical Dispensing, Bulk Manufacturing; 2) Preparation Services; 3) Sterile Filling; 4) Inspection & Packaging, and 5) Manufacturing Administration

Team Supervisory & Development:

• Responsible for interviewing, hiring, onboarding, and the continued training of employees being able to plan, assign, and direct daily work in alignment to site needs.
• Develops, trains, and mentor’s functional supervisors and managers for more effective performance across current assignments. Leads continuous personnel development initiatives and succession planning objectives for ensuring successful business continuity.
• Assures compliance with procedures, cGMP’s regulations, safety, and contract obligations. Reviews documentation produced by management for violations of company policy and recommends disciplinary actions accordingly.

Team & Cultural Leadership:

• Establishes expectations, drives accountability, and influences effective team building to further an established organizational culture based in collaborative teamwork.
• Leads operations managers, supervisors, and hourly staff in addition to working productively with peers across all site work streams.
• Ensures that all site related compliance, quality, transformation, employee learning & development, and financial objectives are met.
• Supports capital planning initiatives for the site in compliance with local, state and federal requirements.
• Sponsors Operational Excellence Program (OEP) improvements as development opportunities for all staff.

The Candidate

Experience and Professional Qualifications

• Minimum 10 years of direct team leadership experience within specific functions to include Operations, Quality, and/or Compliance Management is required. Career experience must showcase an emphasis on team building, problem solving, and employee development inclusive of succession planning.
• Minimum 6 years of progressively responsible work-related experience in designing, customizing, managing, and evaluating manufacturing operations inclusive of programs to support ongoing personnel development are required.
• Undergraduate or advanced educational degree from an accredited college or university within the fields of Science, Packaging, Engineering, or Business are highly preferred but not required.
• Direct parenteral manufacturing and quality related experiences are highly preferred but not required.
• High level proficiencies in employee training, education, and learning development programs with strong group presentation experiences are required. Familiarity with different team management styles, methodologies, and approaches for ongoing personnel development are highly preferred.
• Working proficiency in relational databases or CRMs and computerized software to support management reporting to include word processing, spreadsheets, charts/graphs, and presentations are required.

Skills and Competencies

• Managing People – Showcases advanced competencies in staff planning, decision-making, and facilitating new process improvement implementations. Takes individual ownership and accountability for subordinates' activities making oneself available to all staff for ongoing support. Provides regular performance feedback to encourage individual growth and continue developing subordinates' skills.
• Leadership – Exhibits confidence in self and others being able to inspire and motivate others to perform well. Able to effectively influence the actions and opinions of others in addition to accepting feedback from superiors while giving appropriate recognition to individual team accomplishments.
• Oral/Written Communication – Brings an executive level communication style able to speak clearly and persuasively in both positive and negative situations. Writes clearly and informatively being able to adjust specific writing styles accordingly to meet needs. Presents numerical data effectively and possesses the skillset to translate highly technical concepts for broader group or client understanding.
• Teamwork – Balances team and individual responsibilities to include being objective and having an openness to opposing viewpoints. Gives and welcomes feedback that contributes to building a positive team spirit.
• Strategic Thinking – Develops strategies to achieve organizational goals based on an understanding of the organization's strengths and weaknesses. Leads market and competitor analysis efforts to best identify external threats and opportunities to senior leadership.
• Ethics – Treats people with respect and is accountable to one’s commitments. Inspires the trust of others by working ethically and with integrity to uphold organizational values.
• Organizational Support – Follows corporate organizational policies and related procedures accordingly being able to complete administrative tasks correctly and on time. Champions the organization's goals and values both internally and externally to include supporting affirmative action and team diversity.
• Motivation – Sets and achieves challenging goals by demonstrating a persistence to overcome set obstacles. Individually motivated to grow professionally and take on calculated risks to accomplish goals.
• Planning & Organizing – Prioritizes and plans daily operational work activities for the site to include setting schedules, delegating tasks, developing realistic action plans to unforeseen events, and allocate provided resources effectively.

Physical Requirements for the role include being able to:

• Stand, walk, sit, lift, talk and hear in office, laboratory, and manufacturing work areas
• Administer frequent walkthroughs of shop floor operations

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