QC Analyst III - Cell Culture Team Lead - Memphis, TN | Biospace
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QC Analyst III - Cell Culture Team Lead

Cognate BioServices, Inc.

Location:
Memphis, TN
Posted Date:
9/7/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Cognate is currently seeking an Analyst III- Cell Culture Team Lead for our Quality Control Department. The successful candidate will serve as the lead for performing culturing of various human cell types in support of cell-based immunological product release assays. The team lead will have a deep understanding of the culture methods utilized and oversee the performance and maintenance of procedures as specified in SOPs. The lead will work directly with the area Manager to assist with planning ongoing staff work schedules and staffing needs, as well as assist with overall management of the Cell Culture Team. The team lead will be critical to ensuring documentation is filled out and reviewed by team members accurately and correctly and in a timely manner. The analyst may assist with technology transfer of new client assays by authoring SOPs or other required documentation and/or assisting QC Scientists/Analysts/Managers with needed assay development work.

The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success. The individual should understand GDP and be able to carry out basic analyses of data generated.

ESSENTIAL DUTIES/RESPONSIBILITIES
•   Significant mammalian cell culture experience and understanding
•   Performance of aseptic cell culture (thawing, enumeration, passaging and cryopreservation) of various cell line types required for QC assays.
•   Maintains accurate and timely records of culture manipulations and activities.
•   Enters culture observations and results into the appropriate trending databases for periodic analysis and trending.
•   Works with QC Manager to plan work schedules in advance and assist with team management.
•   Reviews test results of other QC analysts for accuracy and precision and maintains efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
•   Assists the QC Team with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
•   Effectively understands Good Documentation Practices (GDP) and uses as appropriate.
•   Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies.
•   Excellent writing skills. Experience in drafting of Standard Operating Procedures (SOPs), protocols, reports, etc.
•   Ability to problem solve and troubleshoot as necessary
•   Assists with the implementation of quality improvement initiatives for QC laboratory operations
•   Participates in laboratory, OOS, CAPA or other investigations, as required
•   Maintains laboratory supplies, media and reagents inventory
•   Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
•   Responsible for assisting with routine laboratory upkeep and organization
•   Study design, data/statistical analysis, reporting results in both written and oral format (presentation)
•   Experience in Bioassays, Flow cytometry and/or endotoxin testing is an advantage
•   Other duties as required

Requirements

QUALIFICATIONS
•   BS or higher degree in the biological sciences or related field with a minimum of 4 years relevant laboratory experience or experience in a cGMP/FDA regulated industry
•   Ability to work independently and as part of a team
•   Demonstrated knowledge in “core” laboratory techniques (e.g. cell culture/counting, microscopy, etc.) and aseptic techniques required
•   Detail-oriented with strong written and verbal communication skills

•   Ability to problem-solve and troubleshoot as necessary
•   Experience and desire to train current and new staff
•   Experience in equipment and medium qualification preferred

About Cognate
Cognate is a dynamic organization focused on providing a broad range of commercialization services to regenerative medicine and advanced cell therapy organizations. Cognate provides specialized services to companies across all points of clinical and commercial development ranging from early preclinical studies through commercial manufacturing. Cognate applies the expertise of its business, scientific and technical teams to successfully develop biotechnology products across multiple cell-based technology platforms from start to finish.

Employees are our most valuable resource. We are committed to fostering an environment where innovation, teamwork, communication, and recognition are encouraged and rewarded. Cognate offers a competitive base salary, tuition reimbursement, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, prescription, FSA, short/long term disability, life, voluntary life and 401(k). Cognate is an equal opportunity employer that values diversity at all levels.