Downstream Process Development Scientist/Snr Scientist

Position Summary

The Downstream Process Development Scientist/Sr Scientist is responsible for leading the development, optimization, characterization, and tech transfer of downstream manufacturing process for viral vector products, including lentiviral vectors (LVV), adeno-associated virus (AAV), and other gene therapy modalities. This role serves as a technical and client facing leader for development programs, collaborating closely with manufacturing, analytical development, quality, regulatory and external clients to deliver robust, scalable, and phase-appropriate manufacturing processes.  The successful candidate will provide scientific leadership, mentor junior team members, drive technical problem solving, and contribute to strategic process development initiatives that support clinical and commercial gene therapy programs.

Essential Functions and Responsibilities

•    Lead the design, execution, analysis, and interpretation of process development studies for viral vector purification process•    Develop and optimize downstream process unit operations including clarification, chromatography (AEX, CEX, affinity, HIC, SEC), tangential flow filtration (TFF), formulation and fill/finish processes.•    Design statically rigorous studies utilizing Design of Experiments (DoE) methodologies.•    Analyze process performance data and generate technical reports with clear conclusions and recommendations.•    Proactively identify process risks that impact project timeline, actively propose solutions and escalate in timely manner to PD and tech leadership. •    Support technology transfer activities to manufacturing and provide floor support during GMP runs. •    Collaborate with clients and internal/external partners to align development strategies and project objectives.•    Evaluate novel technologies and platforms to improve process performance, productivity, robustness, and cost of goods. •    Maintain accurate and organized experimental records. •    Serve as downstream SME to resolve and drive the closure of investigations and deviations. •    Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. •    Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture. •    Other duties as assigned.

Knowledge, Skills & Ability 

•    SME for downstream processing operations, including chromatography, clarification, tangential flow filtration (TFF), viral filtration, and fill/finish activities.•    Strong attention to details with a demonstrated eagerness to learn and apply new techniques and technologies.•    Motivated to thrive in a dynamic, fast-paced, and rapidly growing environment while effectively managing multiple priorities. •    Demonstrated critical thinking, innovation, and problem-solving skills, with the ability to troubleshoot complex technical challenges. •    Excellent verbal and written communication skills, along with strong organizational, planning, and documentation capabilities. •    Ability to work effectively both independently and collaboratively within cross-functional teams.

Education & Experience 

•    Ph.D. in Biochemical Engineering, Chemical Engineering, Biotechnology, Molecular Biology, Molecular Biology, Cell Biology, Virology, or related discipline with 2+ years of experience; OR•    M.S. with 6+ years of relevant industry experience; OR•    B.S. with 8+ years of relevant industry experience. .•    Experience working in GLP and/or GMP environments, particularly with viral vector process development is highly desirable.

Quality Requirements

•    Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.•    Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.

Working Environment

Onsite Employees: Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.

Physical Requirements 

The physical and mental demands described below are representative of those required to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.While performing the duties of this role, the employee is required to:•    Constantly work in a laboratory environment in proximity to biological materials, chemicals, and technical equipment.•    Constantly wear appropriate personal protective equipment (PPE) in accordance with safety and regulatory requirements. •    Constantly distinguish colors accurately (e.g., interpreting pH strips, test indicators, or assay results). •    Constantly sit and reach while operating computers and other standard office equipment. •    Constantly stand for extended periods, up to four hours at a time. •    Constantly perform tasks involving repetitive motions, including hand and wrist movements. •    Frequently lift and/or move materials weighing up to 20 pounds. •    Constantly use close and distance vision, depth perception, and hand–eye coordination to perform detailed analytical work. •    Frequently communicate verbally and in writing with colleagues and cross-functional partners.

This position requires the ability to work safely in a laboratory setting with potential biological, chemical, ergonomic, and physical hazards while adhering to all safety policies and procedures.

Special Working Conditions

•    May be required to work overtime

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.