The Laboratory Technician II Technical Lead oversees multiple projects simultaneously within the GMP and GMP-S area with a focus on first time right and patient first in full conformance with Quality and EHS requirements. This role assists the buffer preparation team and supervisors as directed, and fills in when supervisors are not available (eg. after hours, during PTO, and unplanned absences).

Responsibilities

• Oversee (from planning through execution) multiple lab technicians/ projects weekly, including a constant state of operational readiness and execution through efficient utilization of staff resources


• Ensure Laboratory Technician II teams are on track and completing projects appropriately through application of technical and regulatory knowledge and experience


• Critically review technical details and proactively work with internal teams to resolve issues


• Ensure appropriate progress against deliverables and timelines; identify and solve technical issues and schedule problems by proposing appropriate risk response strategies when situations arise


• Collaboratively improve and/or troubleshoot laboratory technician II processes


• Instruct and train colleagues on laboratory technician II procedures including change overs, equipment cleaning, checklist items


• Lead training events for trainee’s on production processes when required. Assist with training program as needed


• Support completion and periodic updates on Change Over and Cleaning Standard Operating Procedures and production records


• Provide technical expertise to the laboratory technician team and Technical Writer staff


• Support Initiation and completion of Quality Events, Non-conforming Material Reports and Corrective Action tasks


• Lead Corrective Action investigation work as well as supporting tasks required for the implementation of the corrective action plan


• Perform technical peer review of production records and procedures for accuracy and compliance


• Communicate the status of operations, process issues, and safety and maintenance issues to appropriate area management


• Lead change control requests and subsequent work, as necessary


• Assisting department management with leading the team to prepare facility as 100% audit ready and compliant

Required Skills

• Strong knowledge of computers, Microsoft Office, and Smartsheet 


• Excellent communication that can distill complex concepts with clarity of thought in a concise and factual manner


• Ability to apply scientific and technical knowledge to provide solutions for the advancement of the projects in alignment with specification deliverables


• Ability to use knowledge and interpersonal skills to influence and guide internal team to meet all project and organizational objectives


• Ability to be on call when required.


• Ability to work effectively as part of a team 


• Ability to follow written procedures, and written and verbal directions  


• Ability to keep records and maintain files 


• Ability to adhere to health, safety and sanitation procedures 


• Ability to self-report mistakes or concerns to reporting manager 

Must-Haves

• High school diploma required


• S. or B.S. degree in biology, chemistry, microbiology, or other life science degree preferred


• At least 1-2 years of experience in buffer preparation GMP production activities required

Join Us Today!

Join a team committed to making lives better. Aldevron provides high-quality plasmid DNA, proteins, enzymes, antibodies, and other biologics to help our partners achieve significant breakthroughs for a variety of life science applications.

If you would like to thank someone for referring you to this role, please apply at www.aldevron.com/careers, and include their first and last name as a referral source!

Aldevron is committed to equal opportunity for all employees and applicants. We are committed to creating a diverse workforce and consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identify, or protected veteran status among other factors.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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