Manufacturing Associate II

We are seeking a highly disciplined, energetic, and results-driven Manufacturing Associate II to join our Operations team. This person handles various Manufacturing assignments ranging from routine to complex assignments, requiring sound judgment to solve issues, identify areas for enhancement, and suggest improvements.  Capable of working independently by following standard operating procedures (SOPs) with moderate training and may establish methods and approaches for new tasks and offer support or direction to other junior team members.  Act as Subject Matter Expert in Manufacturing and can leverage their technical expertise to support troubleshooting and continuous process optimization. Under moderate supervision, design experimental plans and analyze resulting data. Capable of prioritizing tasks independently and applying their experience to effectively plan and achieve objectives.  Experience working under ISO 13485 and/or current Good Manufacturing Practice (cGMP) in a biotechnology or pharmaceutical industry is highly preferred.

Responsibilities:

• Formulate standard to complex biochemical and chemical reagents in accordance with manufacturing records, Standard Operating Procedures, and Quality System regulations.
• Perform antibody-oligo conjugations on Hamilton platforms.
• Execute lyophilization of critical components for downstream manufacturing.
• Assist in other manufacturing activities deemed high priority such as filling and packaging, label printing, and special builds, etc.
• Perform batch records review and sign off to ensure completeness and compliance to Quality System standards.
• Support production scheduling and assignment of job duties to team members.
• Provide training, mentoring, and coaching to team members with similar or less experience
• Address and investigate production issues and report any compliance related concerns to supervisor and/or management as soon as possible.
• Ensure equipment and instruments are current with calibration and preventive maintenance, and general maintenance.
• Participate in verification and validation to transfer new products/processes from R&D into Manufacturing, including executing on protocols, gathering data and/or report generation.
• Draft, review, or revise manufacturing documents and procedures.
• Perform change management as required to support product and process change and document change.
• Participation in the selection and training of new employees.
• Act as Lead when Specialist/Supervisor is unavailable.
• Participate in internal and external safety and quality inspections.
• Enforce a safe working environment and compliance with all safety laboratory practices.

Required Qualifications:

• A B.S. or B.A. degree in Biology, Chemistry or equivalent with 3-5 years of relevant experience in reagents manufacturing.
• Strong verbal and written communication skills.
• Hands on experience with antibody conjugation and automated liquid handlers required. 
• Able to work and deliver expected results with a high degree of autonomy.
• Ability to handle multiple tasks and highly adaptive to changing priorities and deadlines.
• Strong organizational skills, detailed oriented, and problem-solving skills.
• Must be a strong team player, self-motivated with “can do” attitude, and willing to learn new techniques and concepts in a fast-paced environment.
• Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.
• Strong proficiency with Microsoft Office suite and experience using manufacturing software, databases and data analytics tools.
• Experience in ISO 13485 and GMP environment a plus.
• Previous experience with ERP System preferred.

 Physical Requirement:

• Able to lift up to 25 lbs. 
• Position requires working in a standing position for long periods of time on a daily basis.

The base salary range for this full-time position is $80,000 - $90,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.