Process Engineering Manager jobs in New Haven, CT

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Salary Range: $158-215k depending on experience and qualifications

Position Summary:

The Consumables Reagent production team at ProteinSimple, a Bio-Techne brand, is seeking a highly motivated and experienced Senior Manager of Reagent Process Engineering to join our team and support the rapid growth of Consumables Reagent production. The successful applicant will support and engage with members of the Consumables Manufacturing team, as well as a multidisciplinary team of engineers and scientists, to sustain and support antibody and protein conjugation, buffer formulation, capillary coating and fluid dispensing processes. This individual will also collaborate closely with our Product Development team and support release of new, novel products for innovative life science technologies.

This position has the potential to grow into a multi-site leadership position requiring up to 25% travel.

Key Responsibilities:

• Leadership

o Technical leader and decision maker for transferring reagent formulation (proteins, antibodies, buffers), surface coating and fluid dispensing processes into production.

o Represent operations in NPI core teams and other transfer projects.

• Operations

o Manage the Process Engineering team to Create and write technical protocols (SOPs). Familiarity with Product Lifecycle Management, creating and submitting Change Orders, Standard Operating Procedures, Bills of Materials, and production documentation.

o Identify and qualify alternate suppliers through approved validation plans.

o Review product non-conformances, support and sustain manufacturing processes using good critical thinking skills and technical knowledge.

o Establish IQ/OQ/PQ of key equipment used in reagent production.

• Process Improvements

o Improve process robustness using production control and lean manufacturing principles.

o Determine scale-up needs and execute projects to maintain growth trajectory.

o Collaborate with R&D to re-define QC specifications, and design and execute validation studies.

o Plan validation exercises (Design of Experiments, FMEA) to demonstrate initial feasibility as well as manufacturing capability.

Qualifications

Education and Experience:

• Minimum 7 years’ experience working in manufacturing/production/process engineering.

• Minimum 5 years as a manager with direct reports in a related field.

• Experience with Lyophilization, Protein purification, conjugation is a plus.

• Strong technical knowledge in biological-based products

• Working knowledge of chemical mixtures, polymers and buffers.

• Track record in programming, setup, operation and data-driven troubleshooting of semi-automated equipment

• Familiarity with handling hazardous materials, solvents, high pressure systems

• Understanding of protein chemistry and bioanalytical techniques for protein analysis and immunoassays is a plus

• Silane/ surface chemistry or Solid works/ mechanical design experience is a plus

• Ability to quickly learn new technologies and implement process controls in a production environment.

• Possesses high integrity and exceptional work ethic. Fosters mutual trust and respect and is a team player.

• Eager to train and give guidance to other employees.

• Excellent communication and presentation skills

• Bachelor’s or advanced Degree in Engineering or Science (Chemical, Mechanical or Bioengineering, Chemistry or relevant field)

Why Join Bio-Techne:

• We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!

• We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.

• We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.

• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.

• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

About the Company:
Advanced Cell Diagnostics, Inc.