Senior Biologist, Cgmp Facility

Atcc Gaithersburg , MD 20877

Posted 3 weeks ago

Overview

Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge.

The Senior Biologist performs a variety of advanced laboratory procedures requiring accuracy, judgment and technical proficiency independently in an ISO 7 and ISO 5 (BSC) cGMP dedicated manufacturing area. The incumbent complies with all ATCC corporate policies and procedures.

Responsibilities

Adheres to quality guidelines such as good documentation practice (GdP) and guidelines to maintain data integrity (ALCOA) per company policy. Ability to be on call 24/7 as necessary to process tissue.

Some weekend and holiday work required. Follows relevant SOPs and procedures with no supervision in a GMP manufacturing environment. Receives and follows work orders, completing work as scheduled.

Communicates effectively with supervisor and others as appropriate on work status. Performs viability and purity checks on biological materials. Demonstrates competence in propagating and authenticating/characterizing a range of biological materials with no supervision.

Maintains knowledge of corporate and program policies and procedures including safety, cGMP manufacturing and Quality standards. Troubleshoots and maintains instrumentation in good working condition and documentation of activities to meet cGMP standards. Create or revise SOPs, policies or other documentation as requested to meet schedule and cGMP manufacturing commitments.

Recognizes critical characteristics of products within relevant area of specialty. Actively acquires new lab skills and specialized knowledge. Reads and understands relevant scientific literature.

Compiles and documents data as directed for technical presentation. Utilizes advance computer skills. (i.e., expertise in the appropriate fields of ATCC's ERP system). Adhere to good documentation practice and guidelines to maintain data integrity per company policy. Participates in technology transfer within ATCC, as appropriate.

Performs advanced assays with no supervision. Offers suggestions for and contributes to optimization of processes. Trains others in laboratory and departmental procedures.

Working Knowledge of aseptic technique and clean room behavior and concept while working in a BSC. When appropriate, participates in scientific meetings, seminars and/or workshops to stay abreast of technology advances. Communicates effectively with members of all programs at ATCC as well as with outside collaborators.

Develops protocols to implement special tests relevant to program specialty. Provides training for CSRs and TSRs, as requested. Develops and evaluates new and/or existing assays for characterization/authentication of biological materials. Performs other duties as assigned.

Qualifications

Education and Experience:

  • Bachelor's degree in a science related field plus 4-8 years of relevant experience OR

  • Master's degree in a science related field plus 3-5 years of relevant experience

  • Minimum of 3 years working in an FDA regulated (or other regulatory bodies) GMP Biopharma facility/industry required.

Knowledge, Skills and Abilities:

  • Advance computer skills including expertise in the appropriate fields of ATCC's ERP system.

  • Serves as a technical expert within relevant scientific discipline.

  • Ability to work independently with minimal supervision.

  • Attention to detail and accountable.

  • Ability to gown and maintain qualification in an ISO 5 and ISO 7 classified areas and work while gowned for an extended length of time.

  • Ability to handle multiple tasks and responsibilities of an advanced nature, simultaneously.

  • Maintains accurate records in a GMP environment and understanding of GxP guidelines and requirements

  • Demonstrates an advanced breadth of knowledge and expertise in relevant scientific discipline.

  • Technical Writing background is highly desirable.

ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any



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Senior Biologist, Cgmp Facility

Atcc