Technical Writer, GMP Manufacturing
AbCellera’s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotech and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.
As a Technical Writer, you will be part of a team responsible for production of innovative bio therapeutic products by interacting with highly automated production systems and controls in a current Good Manufacturing Practices (cGMP) environment. You will play a key role in ensuring compliance with industry standards, regulations and facilitating efficient communication within our organization. You will develop, review and maintain documentation related to processes, procedures and equipment under Good Documentation Practices (GDP) standards. You will also maintain records to comply with regulatory requirements utilizing cGMP within AbCellera’s Single-Use Technology in the Clinical Manufacturing Facility, supporting in the following production areas, such as weighting, dispensing, buffer preparation, upstream manufacturing, downstream manufacturing, aseptic processing filling, tech transfer, automation, supply chain management, facilities and engineering.
We would love to hear from you if:
- You are self-motivated and are able to identify project needs and follow that up with building and implementing solutions.
- You are passionate about building dynamic new teams and capabilities that accomplish important goals.
- You have a bias towards innovation over industry standards.
- You are experienced in creation and revision with both papers based, and electronic versions of Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs).
- You are an outstanding communicator and teammate.
How you might spend your days:
- Documentation Architecture: Developing and implementing a documentation architecture for the manufacturing processes that utilize the various E-Systems.
- Documentation Creation: Developing and maintaining clear, concise, and compliant documentation, including standard operating procedures (SOPs), work instructions, forms, reports, technical manuals, and protocols, following Good Documentation Practices (GDP) principles.
- Working with Facilities & Engineering team to create and revise machine testing protocols including FAT, SAT, IQOQs.
- Process Documentation: Collaborating with subject matter experts (SMEs) to document bioprocessing, quality control, and manufacturing processes. Ensure accuracy and adherence to industry standards.
- Quality Assurance: Reviewing and revising documents for accuracy, completeness, and compliance with regulatory requirements. Implement version control and change management processes.
- Regulatory Compliance: Staying up to date with regulatory changes in the biotechnology industry and ensure all documentation meets or exceeds these requirements.
- Training Support: Assisting in the development of training materials and conduct training sessions for employees to ensure they understand and follow documented procedures.
- Cross-functional Collaboration: Working closely with various departments, including Research & Development, Quality Assurance, Manufacturing, Facilities & Engineering, and Environment Health Safety (EHS) to gather information and improve documentation processes. Participates in cross-functional teams to drive investigation closeouts, determine root cause, and implement appropriate Corrective and Preventive Action.
- Continuous Improvement: Identifying opportunities to streamline documentation processes, improve document accessibility, and enhance overall efficiency in alignment with Lean Management principles.
- Documentation Archive: Maintaining an organized and secure document repository, ensuring easy retrieval and traceability of documents.
- Technical Writing Standards: Upholding high standards of technical writing, ensuring documents are clear, concise, and easily comprehensible by the intended audience. Review documents for logic, clarity, comprehensiveness, relevance and organization, format, flow, grammar, punctuation, and spelling for compliance with customer standards, style guidance, and publication policies.
- Helping to author and revise cGMP documentation (batch records, protocols, SOPs).
- Performing periodic reviews of cGMP documentation to ensure accuracy.
Required qualifications and experience:
- BSc or MSc in a relevant scientific discipline and 4+ years of industry experience working with Good Documentation Practices (GDP) in a pharmaceutical or biotechnology company.
- Proven experience as a technical writer in the biotechnology or pharmaceutical company, with a strong understanding of Good Documentation Practices (GDP), Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP) principles.
- Experience in creation and revision with both paper based, and electronic versions of Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs).
- Excellent written and verbal communication skills, with the ability to convey complex technical information, clearly and concisely.
- Proficiency in document management systems and software tools. Experience with web-based content management systems including templating, HTML5, cascading style sheets, etc. would be an asset.
- Strong attention to detail and organizational skills.
- Sound working knowledge of cGMP, USP, ICH, EP and FDA guidelines is necessary.
- Strong interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
- Experience ensuring timely execution and review of procedures, batch documentation, logbooks, deviations, CAPAs, change controls, and completion of ERP orders.
What we offer:
AbCellera’s hiring range for this role is $65,000 - $85,000, annually, commensurate with your education and job-related knowledge, skills, and experience. We base our salary ranges on localized market data ensuring competitive compensation. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and 6% (non-match) RRSP contribution.
At AbCellera, we have a number of initiatives to support AbCellerites in maximizing their work-life synergy. You will have a $1,500 annual active lifestyle allowance, annual vacation and company-wide office closures (a real value to all!), opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. Abundant team and social groups to build community and connections within AbCellera are a given.
At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You’ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.
We’re a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This isn’t just about having the best technology. We know we need a world-class team of innovators working together to solve the toughest problems. We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success. We’re looking for someone like you to support and organize our efforts along the way.