Sr. Manufacturing Specialist I

In this role, you will provide manufacturing support including technical writing, project management, and process implementation across ASO (Antisense Oligonucleotide), OSD (Oral Solid Dose), and L&P (Label and Pack) teams. This position requires a detail-oriented professional with excellent technical writing skills and a continuous improvement mindset.

Responsibilities

• Serve as the primary receiving-site operational readiness lead for new product and process technology transfer programs.
• Develop, maintain, and drive integrated site readiness plans that align manufacturing startup activities across multiple functions.
• Lead readiness reviews, governance meetings, action tracking, and stakeholder communications to ensure successful execution.
• Identify readiness gaps and proactively escalate barriers that could impact manufacturing startup or operational execution.
• Coordinate critical readiness activities including:
  • Change Controls
  • Material Readiness
  • Equipment Qualification Support
  • Manufacturing Documentation Readiness
  • Training Readiness
  • Floor Support Planning
  • Analytical Readiness
  • Changeover Readiness
• Lead complex cross-functional projects supporting technology transfer, operational readiness, manufacturing improvements, and manufacturing execution while managing timelines, risks, and stakeholder expectations.
• Author and maintain manufacturing documentation including procedures, work instructions, logbooks, changeover protocols, batch production records, solution lot records, investigations, and technical reports with a high degree of accuracy and compliance.
• Lead high-level project management and execution, facilitating timely completion.
• Initiate, own, and manage complex manufacturing-focused Change Controls, CAPAs, Planned Exceptions, and continuous improvement initiatives.
• Lead or support manufacturing investigations, deviation assessments, and root cause analyses using structured problem-solving methodologies to identify causes and implement effective corrective and preventative actions.
• Utilize technical experience, judgement, and precedent to identify, troubleshoot, and resolve straightforward technical and operational problems.
• Proactively identify continuous improvement opportunities, share knowledge cross-functionally, and drive site implementation.
• Partner with cross-functional groups (e.g., Manufacturing, Manufacturing Sciences, Engineering, Automation, Quality, Planning, and Materials Management) to identify continuous improvement opportunities and drive implementation.
• Initiate and own the operational readiness for technology transfer of products into manufacturing and communicate across functional teams to ensure production schedules are met, collaborating with the technology transfer lead.
• Act as subject matter expert for manufacturing processes and equipment while providing technical guidance and operational support during manufacturing execution.

Requirements

• Bachelor's degree from an accredited college or university is required; direct experience may be considered in lieu of degree.
• At minimum 3 years of direct experience in a biotech, pharma, or an industry-adjacent field.
• Prior experience in biopharmaceutical or biotechnology environments with strong knowledge of cGMP regulations.
• Strong root cause analysis and problem-solving experience with the ability to identify trends, investigate issues, and implement effective corrective actions.
• Experience authoring, reviewing, and maintaining technical documentation, procedures, work instructions, investigations, and manufacturing records.
• Intermediate to advanced skills in Microsoft Office and computer-based quality systems.
• Experience in Continuous Improvement, Operational Excellence, Manufacturing Excellence, or Process Improvement programs.

Preferred Qualifications

• Lean Manufacturing and/or Six Sigma training or application experience.
• PMP certification or formal project management training.

Schedule

Monday-Friday from 8 AM – 5 PM, standard business hours. This site-based role primarily supports manufacturing during core weekday business hours but may require infrequent off-hours support.

Pay

The base compensation range for this role is $98,000.00 - $127,000.00. Base salary offered is determined through an analytical approach utilizing factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity opportunities.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown (Dec 26-Dec 31)
• Up to 12 company-paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company-matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation