This position reports directly to the head of Drug Substance and requires effective leadership, coaching and performance management of 2-8 manufacturing leaders responsible for facility start-up and execution of cGMP purification operations.

Lead implementation of innovative and cost-effective technologies, design practices and best-in-class business processes to enable on-time and on-budget facility startup. Oversee all aspects of the manufacturing operations, including production planning, scheduling, resource allocation, and capacity management. Ensure adherence to production schedules, quality standards, and regulatory requirements.

The Purification Operations Manager will be responsible for actively directing and engaging in work to support the following two phases of the Hopewell manufacturing facility:

• Facility start-up and CQV execution

• High volume reliable cGMP Manufacturing

Required Leadership Skills (Phase I & II)

• Lead and mentor a diverse team of manufacturing professionals, fostering a culture of collaboration, accountability, and continuous learning.

• Strategic and tactical planning with ability to convey priorities and business relevance to team with ease

• Ability to develop and communicate objectives to support time-sensitive priorities that deliver consistent business results.

• Provide guidance and support to team members to support enable attainment of assigned objectives

• Provide coating and mentoring in support of team’s professional growth and development.

• Writing and delivering effective performance appraisals and managing performance issues.

• Effectively receives and provides feedback as appropriate

• Planning and managing day-to-day activities, including resources and task loading

• Self-directed leadership with ability to bring clarity to team within ambiguous work environments

• Inclusive and cross-functional collaboration with all levels of organization, external stakeholders as well.

• Able to cultivate culture of continuous improvement and right first-time quality

• Thoughtfully escalates issues/concerns in a timely manner as appropriate- resolves whenever possible.

• Project management and working through competing priorities

• Recruiting, interviewing, and selecting key talent

• General Description: This position reports directly to the head of Drug Substance and requires effective leadership, coaching and performance management of 2-8 manufacturing leaders responsible for facility start-up and execution of cGMP purification operations.

• Lead implementation of innovative and cost-effective technologies, design practices and best-in-class business processes to enable on-time and on-budget facility startup. Oversee all aspects of the manufacturing operations, including production planning, scheduling, resource allocation, and capacity management. Ensure adherence to production schedules, quality standards, and regulatory requirements.The Purification Manager of DS will be responsible for actively directing and engaging in work to support the following two phases of the Hopewell manufacturing facility:

• Facility start-up and CQV execution

• High volume reliable cGMP Manufacturing

• Required Leadership Skills (Phase I & II)

• Lead and mentor a diverse team of manufacturing professionals, fostering a culture of collaboration, accountability, and continuous learning.

• Strategic and tactical planning with ability to convey priorities and business relevance to team with ease

• Ability to develop and communicate objectives to support time-sensitive priorities that deliver consistent business results.

• Provide guidance and support to team members to support enable attainment of assigned objectives

• Provide coating and mentoring in support of team’s professional growth and development.

• Writing and delivering effective performance appraisals and managing performance issues.

• Effectively receives and provides feedback as appropriate

• Planning and managing day-to-day activities, including resources and task loading

• Self-directed leadership with ability to bring clarity to team within ambiguous work environments

• Inclusive and cross-functional collaboration with all levels of organization, external stakeholders as well.

• Able to cultivate culture of continuous improvement and right first-time quality

• Thoughtfully escalates issues/concerns in a timely manner as appropriate- resolves whenever possible.

• Project management and working through competing priorities

• Recruiting, interviewing, and selecting key talent

• Required Skills/Experience

• Facility and equipment design, installation, commissioning, qualification, and validation

• Proactive management of GMP deviations, assessments, investigations & CAPA’s

• Effective health authority interactions

• Quality risk management (QRM)

• Ability to ensure compliance with all relevant regulatory guidelines, including FDA, EMA, and other applicable regulatory bodies (e.g. OSHA).

• Provide input for budget forecast projections and ensure optimal resource utilization

• Identify and implement cost-saving initiatives without compromising quality or safety

• Generation and review of design documentation and validation protocols

• Automated process control systems (e.g., DCS)

• CIP & SIP of fixed stainless-steel vessels and transfer lines

• Solution preparation and transfer

• Chromatography and column packing

• Viral filtration

• Ultrafiltration Diafiltration (TFF)

• Bulk Substance Fill

• Integrity testing

• Aseptic sampling

• Analytical Instrumentation (conductivity, pH etc.)

• Good Documentation Practices

• Equipment and process troubleshooting

• Authoring SOP’s, MBR’s & WI’s

• Delivering technical presentations

• Preferred Skills/Experience

• OE and/or LEAN Methodologies

• SAP, LIMS, CMMS, Veeva

• Professional Experience

• Minimum of 5 years of experience working in Biopharmaceutical manufacturing

• Minimum 3 years formal leadership experience within biopharma industry

Physical Requirements :

• Must be able to stand for long periods, up to 8 to 10 hours/day.

• Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.

• Must be able to work scheduled at least 40 hours/week.

• Must be comfortable in working in varying temperatures.

• Frequent lifting, pushing, pulling, and carrying. Ability to lift up to 40 lbs.

• Regular reaching, bending, stooping, and twisting.

• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.

• Environment requires dedicated gowns, depending on area.

• Work with hazardous materials and chemicals.

Willing to work any shift.

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.