Manager, Molecular Biology

Manages the Molecular Biology operations and staff to ensure day-to-day testing operations are performed. Demonstrates leadership in a fast-paced setting and operates with minimal oversight and a clear understanding of business and regulatory demands. Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of Molecular Biology, and excellent understanding of current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) compliance requirements. Efficiently manages staff and other resources to address scientific, business and regulatory needs in an effective and timely manner. Interacts with internal and external customers and auditors as needed to provide support and address any comments/issues. Leads process improvements and performance metrics for the Molecular Biology operations team. Remains current regarding best practices and develops or modifies procedures to stay fully compliant with the evolving expectation of all clients. Prepares protocols and standard operating procedures (SOPs), and reviews and approves work of team members. Schedules, manages, and conducts testing activities, keeping appropriate records consistent with regulatory guidance, business needs and client expectations. Gather and collate results, identifies trends, interprets implications, and recommends procedural changes to drive improvement. Communicates with Management, Quality Assurance and other as appropriate. Participates in development and implementation of validation plans and protocols. Effectively assists with client and regulatory interactions as appropriate.

• Supervises, plans, & reviews operations for department, including training.
• Recommends personnel actions and manages employee relations including performance reviews.
• Demonstrates leadership and is supportive of company goals and objectives.
• Responsible for leading the on-time completion of client sample testing in a cGMP compliant manner within the department
• As assigned by management, acts as a technical reviewer for select assay and assumes all associated responsibilities.
• Conducts critical review of test results and reports data to appropriate employees.
• Interacts with all departments to assure that appropriate testing information is effectively communicated.

• Interacts will client to address scientific related issues and project planning.
• Ensures quality control testing is scheduled and performed
• Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining standards
• Recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems
• Provides strong in-house guidance on science and technology
• Interacts with internal staff to identify assays requiring further improvement or development and oversees improvement of these assays
• Travels with other WuXi AppTec staff to visit clients as appropriate
• Responsible for appropriately conducting assays in accordance with cGMPs
• Assures that laboratory personnel are following all company SOPs and safety rules
• Prepares and revises technical documents (Laboratory Protocols, SOPs, etc.)
• Assures that batch records and other paperwork are completed according to cGMPs and company SOPs
• Provides operational support for Molecular Biology activities including (Ex. media/buffer preparation, cleaning activities, and equipment/materials staging/ Aseptic Technique).
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Works under close supervision from senior personnel.
• Ability to work in a team environment and independently as required
• Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work
• Plans, monitors, and appraises direct reports including performance competencies, goals & job results
• Coaches, counsels, and conducts disciplinary actions
• Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
• Maybe required to work Holidays and weekends
• Contributes to the overall operations and to the achievement of departmental goals

• HS Diploma or equivalent required and
• 5+ years relevant technical experience and min 2 years Managing people
• BS/BA in Science related field preferred; or combination of relevant Experience & Education

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.