What are the responsibilities and job description for the Sr Manager of Downstream Process Development position at Cytovance Biologics?
Job Description:
GENERAL SUMMARY:
The Sr. Manager of Downstream Process Development will lead a laboratory-centered group of scientists, engineers and associates that develops clinical drug substance (DS) processes for clients in a manner consistent with established scopes and timelines. The candidate should have previous leadership experience as well as advanced knowledge of principles, concepts and practices in the discipline he/she will be leading or in a related discipline. Since each phase of clinical study requires sufficient information to establish the identification, quality, purity and strength of the DS, the candidate should be aware of phase-appropriate considerations to apply to process design and definition. It is highly desirable that the candidate have a track record of successful project completion across the different clinical phases and have extensive knowledge of GMPs, control strategy concepts, scale-up/-down methodologies, risk assessment processes and statistical design-of-experiments. In addition to managing client projects, the candidate will be required to identify gaps and apply innovation to drive continuous improvement in collaboration with open innovation and other group leaders.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Oversees all the scientific and engineering aspects of process development, process demonstration, scale-up/-down, and process characterization for biologics DS processes including but not limited to monoclonal antibodies, fragment antibodies, enzymes, bi-specifics, vaccines and fusion proteins
• Serves as the group’s subject matter authority figure and represents group in client-facing project team meetings; sets high standards for technical documentation
• Demonstrates excellent communication inside and outside own group and strives to stay aligned with corporate policies and practices while ensuring seamless technology transfer from process development to manufacturing
• Manages multiple client and internal projects while defining and prioritizing the activities of individual team members
• Mentors and trains team members through the practice of active listening and regular feedback
• Drives alignment with peer level colleagues in other R&D groups to ensure seamless hand-off points (materials and information)
• Generates technical and scientific content for corporate marketing purposes and attends scientific conferences to speak on behalf of Cytovance Biologics
• Helps business development evaluate new client project opportunities
JOB REQUIREMENTS:
• Ph.D. in biochemistry, bioengineering, or related field with at least 8 years of experience in the downstream processing area of biotech industry. Previous hands-on downstream PD experience in CDMO is highly desirable.
• Candidate must have strong hands-on experience for downstream process development and people and project management skills with proven records.
• Strong written and verbal communication skills
• Proficient computer skills including MS Word, Excel, PowerPoint, control software, JMP
PHYSICAL DEMANDS:
While performing the duties of this job, the employee is frequently required to stand; sit and talk or hear. The employee is occasionally required to walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl.
WORK ENVIRONMENT:
While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
Cytovance Biologics acknowledges that providers may be a valuable resource for identifying and recruiting Candidates for employment. However, we require that all external recruiters engage directly with Cytovance Biologics Human Resources Team and comply with Cytovance Biologic’s requirements prior to transmitting any Resumes/CV’s or introducing any candidates to an employee of Cytovance Biologics. Cytovance Biologic’s Human Resource Team is the only function within the Company that can enter contractual relationships with external recruiters and recruiting agencies.
