Senior Process Development Scientist – Illinois
Provides an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position. Assumes the role of technical expert in developing and improving specific protein purification processes. Responsible for leading studies in support of R&D process development, process improvement, or manufacturing support projects. Responsible for leading the development of possible therapeutic indications for identified plasma proteins.
- Collaborate with other departments and lead technical development projects.
- Maintain an advanced level of documentation and communication through timely and thorough drafting and execution of protocols, reports, and experimental summaries in support of process development activities.
- Coordinate scientific and investigative studies through collaboration with internal customers, academic research organizations, contract laboratories, & external R&D groups within CSL. Think creatively and provide technical justification for novel concepts and approaches.
- Assume larger roles within & outside the company and responsible for leading interdisciplinary projects and teams toward successful accomplishment of objectives. Keep a high level of scientific excellence by regularly attending regional and national technical meetings and publish in peer-reviewed journals whenever possible.
- Anticipate potential problems, design preventative, and implement innovative solutions.
- Maintain a high awareness of production processes and be proactive in introducing improvements for product yield or quality.
- Perform fundamental literature & patent searches related to activities and develop alternative strategies, if necessary. Research on projects to determine logistical impact & to ensure compliance with regulatory and industry guidelines, master plans, and company policies and procedures.
- Maintain equipment and calibrations per established R&D policies and SOPs. Also responsible for updating existing and developing new SOP, as required, to maintain a cGMP environment in the laboratory.
- Actively seek new opportunities, contribute key ideas to projects, and promote area of expertise to achieve results through participating in national and international organizations, such as Pharma, PPTA, PDA, etc. that influence industry standards and FDA policies.
- Maintain an awareness of and compliance with current Good Manufacturing Procedures (cGMP).
- Mentor, provide guidance, and training less senior personnel. Assume a leadership role in providing solutions to difficult problems associated with specific projects.
- BS/BA with 5 to 8 yrs. experience, or a MS/MA with +3 yrs. experience, OR a Ph.D. with 0 to 2 yrs. experience
- Strong knowledge base in of and expertise in other areas of the plant operations, such as fractionation, downstream protein purification, parenterals, QC/QA, etc., and extensive experience in cGMP and other regulatory requirements.
- Knowledge and competency in a wide range of protein purification techniques.
- Experience in collaboration with groups inside and outside the company.
- Excellent written and oral communication skills.
- Strong leadership, coaching and mentoring skills needed to facilitate knowledge sharing. Fully proficient in functional/technical problem solving, time management, and proven organizational and interpersonal skills.
- Proven problem-solving abilities, creativity, and efficient time management.
- Efficient analytical and conceptual thinking and efficient use of networking, and decisiveness is required.
- Cross-cultural-sensitivity, action-orientated while directing others.
This global organization is one of the world’s leading pharmaceutical companies with a comprehensive line of therapies dedicated to the treatment of hemophilia, immune, wound-healing, and other coagulation disorders. They have experienced phenomenal growth over the past decade and are in the midst of a 10 year, $1B expansion, increasing capacity by 300% at the site! They offer a fantastic work culture dedicated to employee growth with a philosophy of “We know that when our employees grow individually and professionally, the company grows with them – and patients get the best care and attention they need.” Apply today!