Just-Evotec Biologics is seeking a highly motivated Downstream Process Engineer for site MSAT to join a fast-paced, collaborative, and multidisciplinary team. The role report to Downstream Lead for site MSAT, and will be responsible to support all aspects of downstream processing for multiple clinical-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations.
Roles and responsibilities:
- Represents site MSAT on project teams as technical subject matter expert (SME) and interface with global MSAT, Operations and Quality functions.
- Develop process understanding and expertise.
- Authors, reviews and owns process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc)
- Authors, reviews change controls including managing change implementation of the change as the assigned change agent.
- Partner with Quality, Validation and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration.
- Act as a subject matter expert for regulatory and client inspection audits.
- Utilize technical skills and process knowledge to participate and/or lead investigations related to process/ New product implementation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
- Monitors and reports on process performance data analysis
- Ability to share 24/7 on call support activities during production.
- Apply Operational Excellence principles to lead continuous improvement for downstream process improvements.
Position Requirements:
- Masters (or Bachelors) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience including a minimum of 2+ years of supporting downstream purification activities for biopharmaceutical products.
- Knowledge and experience CMC stage gates for clinical and commercial biologics drug substance manufacturing programs.
- Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
- Technical purification and solution preparation operations using disposable-based manufacturing technologies
- Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders
- Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing
- Good interpersonal, team, and collaborative skills are required.
- Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
Additional Preferred Qualifications:
- Experience in supporting audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff.
- Experience in leading risk assessment and risk management for pharmaceutical products and processes. Experience in applying principles of Quality by Design.
- Entrepreneurial drive to achieve business objectives.
This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.
The base pay range for this position at commencement of employment is expected to be $91,560 to $125,350; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
Top Skills
What We Do
Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients.
Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing.
We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI.
We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.
