Lead, Technical Transfer

Socket.dev; Verona (WI); On-site; USD 85,000 - 98,000; Full time

Benefits offered by this job

Excellent benefits

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a GMP technical transfer specialist to lead doc development and transfer activities between process development and manufacturing.

You will craft batch records, SOPs, and related GMP documents while coordinating across multiple teams to ensure readiness for new and existing programs. The role requires a BS/BA in a scientific field and 3+ years in GMP settings with tech transfer experience.

Qualifications

• BS/BA in chemistry, biology or biochemistry required.
• 3 years GMP experience with at least 1 year in technical writer or tech transfer.
• Proficient with controlled documentation and CAPA investigations.

Responsibilities

• Lead technical transfer activities to support manufacturing readiness.
• Write and develop GMP batch records, methods, and SOPs.
• Coordinate process transfer activities across cross-functional teams.
• Manage project timelines and provide milestone updates.
• Lead deviation investigations and implement corrective actions.
• Compile master data and review executed batch records.
• Collaborate with departments to achieve project readiness goals.
• Occasionally assist with laboratory work as needed.

Skills

Cross-functional collaboration

Project management

Attention to detail

GMP documentation

Microsoft Word/Excel

Education

BS/BA in chemistry, biology, or biochemistry

Tools

Microsoft Word

Microsoft Excel

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

This position will be primarily responsible for leading technical transfer activities to support manufacturing readiness. This includes writing and developing GMP batch records, methods, and other necessary documentation to ensure effective process transfer between process development and manufacturing groups. They will assist with writing and updating SOPs and technical documents pertaining to GMP operations. The position is also responsible for coordinating process transfer activities for new and existing programs across cross-functional teams.

• Work between process development and manufacturing scientists to create and maintain production batch records and process documentation for new and existing programs.
• Facilitate cross-functional coordination and input to document new methods
• Manage project timelines and provide project milestone updates to internal team members
• Identify and implement best practices and process improvements to technical transfer activities and documentation
• Lead deviation investigations and implement appropriate corrective action as necessary.
• Contribute to the compilation of master data
• Write SOPs pertaining to GMP production.
• Perform reviews of executed batch records
• Work with different departments to achieve project readiness goals
• Occasionally assist with laboratory work as needed

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
• 3 years working in a GMP setting with a minimum of 1 year of experience in a technical writer or technical transfer position
• Proficient experience working with controlled documentation
• Experience with internal CAPA investigations
• Proficient project management skills
• Ability to collaborate with and coordinate cross-functional teams
• Proficiency with Microsoft Suite applications (Word, Excel)
• High attention to detail
• Ability to multi-task and manage responsibilities within ongoing projects

Preferred:

• 5+ year's GMP experience and 3+ years tech transfer experience

Wisconsin pay range: $85,000 - $98,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.

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