What are the responsibilities and job description for the QC Consultant, Biologics position at Pharmatech Associates, a USP company?
Pharmatech Associates is seeking QC Consultants to provide consultation services to our pharmaceutical, biologics and medical device clients. The nature of our projects varies from client to client and can often be supported remotely.
Typical Project Responsibilities Include
Typical Project Responsibilities Include
- Support method transfers, method development, and method validations
- Performing gap assessments of test methods and laboratory operations, including contributing to associated reports
- Drafting/reviewing quality control SOPs and product specific test methods
- Delivering overall expert project management and consultancy services
- Reviewing and providing input to critical/complex deviation or out of specification investigations
- Conducting risk assessments and identifying actions to mitigate risks
- Reviewing stability study protocols and summarizing time-point data
- Developing sampling plans for material, components and product testing
- Summarize data for inclusion in annual reports, prior-approval submissions or BLAs
- Master’s Degree or Ph.D in molecular biology or cell biology or biochemistry or related fields
- At least 15 yrs of analytical development and/or QC experience total with at least 5 in a well-known biopharmaceutical company, and at least 8 of which in a GMP environment.
- Proven track record in supporting late-stage and commercial biologics product testing in a managerial position or above.
- Familiar with analytical control strategy for typical biologics products such as Monoclonal antibodies, cell and gene therapy (e.g., CAR-T)
- Proven deep technical skills in at least two specific analytical technologies, physical chemistry, or potency assays including cell-based assays.
- Familiar with specification setting principles, and stability studies for biologics.
- Ability to lead projects, where required, manage work to a defined scope of work and meet crucial timelines
- Superb written and oral communication skills
- Excellent interpersonal and soft skills
- Ability to solve problems using innovative techniques
