Analytical Development Associate, Senior

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein, and cell and gene therapy-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

SUMMARY:

We have an exciting opportunity for a Senior Analytical Development Associate to join the Process Development team at AGC Biologics in Longmont, Colorado. This is a great opportunity to lead the development of analytical methods in support of client projects and technology transfers across sites, as well as lead in the characterization of for cell and gene therapy process. Additionally, this position will support the transfer and implementation of new analytical technologies into Process Development (PD) and Quality Control (QC) operations.  With limited supervision, this person leads routine to complex experiments or methods and method development in support of key strategic near and long term capabilities at the site. 

PRINCIPAL RESPONSIBILITIES:

• Perform cell and gene therapy analytical assay development for potency, identity, chemical and physical characteristics, safety, and impurity. Expertise in Flow cytometry, ELISA, ddPCR, qPCR, viral titer and infectivity,  sequencing, clarity, pH, osmolality, residual assays required
• Provide internal process analytical supports, and lead method transfer to process development and QC teams.
• Participate in the design and execution of experiments aimed at delivering on the departmental vision, under the supervision of the Manager of Analytical Development and in collaboration with AGC Biologics PD and QC personnel.
• Work collaboratively within the PD organization, cross-functionally across the QC organization, as well as internationally in collaboration with the European sister facility in Milan, Italy to share knowledge and expertise fluidly across the sites.
• Evaluate external analytical technologies and manage external collaboration projects.
• Lab management (e.g. coordinating instrument training and maintenance, consumable ordering) as required of the role.
• Day-to-day operations required to support the Analytical Development work in Longmont, Colorado.
• Interact with clients as needed to explain complex methods and provide technical support to the Business Development organization.

KNOWLEDGE, SKILLS & ABILITIES:

• Self-motivated, organized and proactive.
• Excellent knowledge, experience, and independence in analytical method development for the characterization in biotech industry.
• Strong interpersonal and team skills, including the ability to work collaboratively in a fast-paced cross functional environment.
• Strong data management skills and attention to detail in the execution and documentation of studies.
• Good mechanical aptitude and confidence working with computers and analytical equipment
• Excellent written & oral communication skills and technical ability
• Proven technical ability to successfully problem solve and troubleshoot
• The ability to work with limited supervision and in a team setting
• Willingness to support limited evening and weekend work, as needed
• Able to lift 30 pounds and have good manual dexterity to work in a laboratory environment
• Dependable, detail-oriented, organized, and willing to perform both routine tasks and develop new skills

EDUCATION/EXPERIENCE:

• A./B.S. in a life science or engineering with 8+ years of relevant experience or Masters with 3+ years of relevant experience
• Demonstrated experience in an Analytical Development lab environment

COMPENSATION RANGE:

$94,000 - $129,250

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.