QC Scientist Manager

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Job description

**Kelly Services is currently seeking a** **QC Scientist Manager** **for a Direct Hire role in** **Lexington, MA** **.**

**Job Title** : **QC Scientist Manager**

Pay: $150 - 158k depending on experience

The company is a clinical-stage Biopharmaceutical company that discovers, develops, and manufactures immuno-oncology products comprised of checkpoint antibodies, cell therapy and adjuvants representing a combination of synergistic agents to deliver curative patient outcomes. The Quality Control (QC) Bioassay Sr. Scientist/Manager will establish, develop, and lead the Bioassay function overseeing internal validation/qualification and tech-transfer of cell-based functional assays.

**Roles and responsibilities** :

• Establish and lead QC Validation, ensuring QC operations comply with cGMP throughout the lifecycle of biological product development

• Supervises, plans, and reviews operations for assigned staff, including responsibility for training, managing, and evaluating, as well as coordinating, scheduling, and assigning work

• Demonstrates innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures as it relates to Analytical methods, and cell-based potency assays

• Establish, develop, and/or optimize analytical methodology to test the potency of protein products (in-process and final) using binding or cell-based assays

• Provide expert scientific advice in relation to the development/tech-transfer, validation, implementation, and continuous improvement of novel cell functional assays and other peptide-based products.

• Independently lead investigations in collaboration with QA to address change control, deviations, Out-of-Specification (OOS) and oversee the implementation of effective corrective/preventive actions

• Authors risk assessment, standard operating procedures (SOP), method transfer and validation protocols and reports as required to support QC Bioassay and general operations

• Support Regulatory submissions (e.g., IND/BLA), authoring/reviewing/approving CMC sections and participating/assisting regulatory inspections and information requests.

**Qualifications and Education Requirements** :

• A least 8+ years of relevant experience with cell-based assay or equivalent for Bachelors', 5+ years for Master's in the Quality Control or related field or equivalent experience.

• Experience in qualification and/or validation of cell-based and immunological bioassays for GMP lot release and well-versed in cGMP/ICH/FDA/EU regulations and guidelines

• Experience responding to health authority (FDA, EMA, etc.) information requests and participating in FDA audits

• Ability to work within established timelines and manage changing priorities in a fast-paced environment

• Ability to comprehend and draw conclusions from scientific and numerical data

**Preferred Skills** :

• Experience with cell-based assays and their application in biological characterization for biologics required

• Exceptional leadership skills, demonstrated experience working and collaborating with cross-functional biologics development teams

• Superior interpersonal skills and ability to work with people with varying backgrounds and skill sets

• Excellent written and verbal communication skills coupled with the ability to prioritize multiple tasks and have the confidence to challenge existing systems & processes

• Innovative, critical-thinking QC scientist knowledgeable in the application of ICH Q8/Quality by Design (QbD) principles to the development and continuous improvement of bioassays throughout the product lifecycle

• Capable of working independently in a high-paced team environment, prioritize work for multiple projects and meet deadlines

**Competencies Needed** :

• Ability to use proficiently advanced laboratory equipment, such as, but not limited to, automated cell counters, plate readers, etc.

• The ideal candidate will have experience working with CBER either with cancer vaccines or cell therapy.

**Why Kelly** **®** **?**

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** **®**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ()