Job Title: Quality Control Lab Manager

INTERESTED CANDIDATES MAY SEND UPDATED RESUMES TO: MAMCDONOUGH @ ACTALENTSERVICES.COM

OR TEXT MARISA TO SETUP PHONE INTERVIEW: 330. 397. 1302

Job Description

Utilize your management experience and expertise in lab operations to support in-process testing and characterization of intermediates as well as release and stability testing of gene therapy products. Work closely with other Laboratory Services groups to provide required analytical testing support, hire, develop, and lead a team of scientists in the execution of analytical testing programs for gene therapy products. Support the characterization and testing of gene therapy drug products consistent with US FDA and EMA regulatory guidelines and expectations for gene therapy products in early and late stages of clinical development.

ResponsibilitiesReview and approve technical and scientific documents including study protocols and reports, qualification/validation documents, SOPs, and test methods.Collaborate effectively with research, CMC team, and clients to support IND enabling activities.Exercise discretion, judgment, and personal responsibility.Respond to, and take action from, alarm notifications from the applicable monitoring system(s) for laboratory temperature-controlled storage units that occur at any point during the assigned period of responsibility.Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF.Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.Ensure attention to detail in all job functions.Perform in accordance with established policies, procedures, and techniques requiring training, common experience, or working knowledge related to the tasks performed.Anticipate problems and remove obstacles to enable staff to perform tasks as assigned.Work to specific measurable objectives requiring operational planning skill with little direct supervision.Cultivate a diverse and collaborative team environment utilizing clear and concise communication to deliver high productivity and contribution to the success of department goals.Develop and enforce procedures and controls.Drive development of procedures.Manage budgetary responsibilities.Participate frequently in audits.Maintain frequent involvement in customer relations.Hold significant responsibility for inspection outcomes.Oversee hiring, development, and related personnel processes.Mentor and provide professional development for staff.Exercise crucial people skills.Manage and influence people in direct and lateral support structures.Have significant latitude for making decisions for their operational or functional unit.Drive timelines and development through broad influence.Essential SkillsExperience in life science, biotechnology, or molecular biology.Proficiency in GMP, FDA, and quality assurance standards.Relevant four-year degree, Master’s, or PhD preferred.Seven years of experience in QA/QC.Prior management or supervisory experience.Broad knowledge of the field with demonstrated leadership skills.Excellent communication, organization, and project management skills.Proficiency in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.Ability to work independently as well as collaboratively in a diverse and inclusive work environment.Client-focused mindset in daily tasks.Experience handling confidential information and ability to maintain confidentiality.Additional Skills & QualificationsExperience in life sciences, biotechnology, or gene therapy industries.Work Environment

This is a lab and office-based environment with time split between the lab and desk work. The dress code is business casual, and PPE for the lab is provided. This is a 2nd shift role with hours roughly 1-9:30 PM, with some flexibility based on need.

Pay and Benefits

The pay range for this position is $75000.00 - $90000.00/yr.

Medical Insurance and Prescription Drug Coverage.
Dental Insurance and Vision Coverage.
Health Savings Accounts.
Flexible Savings Accounts.
401K - Retirement.
Paid Time-Off (PTO)
Company Paid Short-Term and Long-Term Disability.
Life Insurance.

Workplace Type

This is a fully onsite position in Columbus,OH.

Application Deadline

This position is anticipated to close on Feb 24, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.