Associate Director R&D Pilot Plant

Position Purpose: 

The Associate Director , PPD Clinical Operations is a highly motivated process scientist/engineer capable of developing and applying innovative and compliant approaches to the GMP manufacture of investigational medicinal protein products.

This Associate Director will be responsible for leading a team which will manufacture GMP clinical trial material for CSL Behring’s programs.  This position leads teams of scientists and engineers and is responsible for the pilot scale GMP manufacture of bulk purified protein.  This person will also be responsible for the buildout, daily operation, and hiring of the pilot plant lab to enable a core functionality within CSL Behring’s PPD Clinical Operations team.  They are expected to provide technical and scientific expertise and leadership for process optimization, scale-up, technology transfer and troubleshooting.  The ideal candidate should have experience with scale-up of downstream unit operations with an emphasis on downstream purification including chromatography, filtration, TFF, etc.

• This position reports to Sr. Director, Process Development and Global Pilot Plant Department within Plasma Product Development (PPD)
• This position involves the direct supervision of Senior Scientists, Scientists, & Engineers

Main Responsibilities and Accountabilities: List the roles and responsibilities of the position

1. Provide scientific leadership and project management for multiple early stage development projects (plasma derived products, gene therapy, etc.).  Detailed planning, co-ordination, implementation, tracking and communication to ensure material delivery.

2. Take ownership responsibility for the successful completion (as measured by product yield, quality & consistency, and the achievement of Project timelines) of manufacturing campaigns.  Manage pilot plant operations and prioritize production schedule to support multiple CSL Behring projects.

3. Management of team of Senior Scientists, Scientist and/or Associate Scientists.  Oversees downstream purification processing activities as well as discrete facility continuous improvement projects.  Provides direction, guidance, coaching and performance management as appropriate.  Hire additional staff to support routine operations and pilot scale activities.

4. Leads the team who generates and approve technical documents including batch records, SOPs, EOPs, development reports, and risk assessments.

5. Champion a center of excellence for PPD with GMP pilot plant capabilities with a focus on delivering clinical trial material and driving for continuous process improvements

6. Maintain awareness of and compliance with cGMPs.  Coordinate activities with PPD pilot plant to assist with manufacturing scale-up, process development activities, operation support, and new plasma product development.

7. Prepares for Regulatory Agency inspections and internal quality; serves as the lead manufacturing contact.

8. Assist in the preparation of the annual operating budget and monitor & control costs.

9. Be flexible and adaptable to changes in project and workplace priorities.

10.Ensure high safety standards within the areas of responsibility are considered and adhered to as governed by local, state, and federal regulations, laws, and policies as well as CSL’s policies and directives.

Position Qualifications and Experience Requirements: 

Education

Ph.D. in Biotechnology, Engineering or related discipline with relevant industry experience or B./M.Sc./Eng. with substantial experience in process development relating to manufacture of therapeutic proteins for clinical investigation.

Combination of education and appropriate experience. BS in Biochemistry, Engineering or other Scientific discipline + 10 years. MS +7 years, PhD +5 years needed to establish a strong background and knowledge base.

Experience

• Complete theoretical understanding and extensive practical experience for developing and supervising/conducting GMP pilot-scale processes and protein purification for clinical operations.
• Comprehensive and thorough understanding and extensive practical experience with GMP quality systems and procedures.
• Thorough grasp of Regulatory guidance’s such FDA, EMA, and ICH.
• Strong pilot-scale process and product data analysis skills, and practical experience for the establishment of process and product specifications (and quality systems/procedures for management of specifications) of new investigational medicinal products.
• Strong knowledge and experience of raw material options, suppliers, and quality requirements.
• Proficient initiative to work independently and in cross-functional teams both locally and globally.

Competencies

Experience with leading teams and overseeing transfer of product from development scale to full manufacturing.  Organization and interpersonal skills, excellent technical writing and oral communication skills.  Proven leadership and track record of successful development and process improvement projects. Coaching/mentoring skills to facilitate knowledge sharing.  Problem solving abilities, creativity, efficient time management, analytical and conceptual thinking.  Efficient use of networking. Decisiveness, action oriented.  Organizational Agility, global business knowledge, Motivating Others.

Qualifications:
• Postgraduate degree (preferably MSc or PhD) and / or experience in relevant discipline.
• Minimum of 3 years' relevant industry experience and / or equivalent experience in a relevant academic environment.
• Demonstrated ability to work within and contribute to highly effective teams.
• Experience working in cross-functional, multicultural and international teams.
• Experience in project work and excellent analytical skills.
• Excellent communication skills (English language).

 

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CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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