The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.
CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.
The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.
The Technical Writer will assist in the creation, review, and revision of documents and other computer systems documents. Individual will work with multiple operations to understand the objective of each document to ensure that all documents contain the required content. Individual will interpret information and organize it properly for accuracy, readability, and format, while ensuring the proper grammar and spelling is used in all documents. Perform all duties in a manner consistent with site and corporate cGxP, safety, environmental and human resources policies and procedures.
- Edit and format incoming requests for new or revised documents (SOPs, forms, jobs aids, technical documents, etc.) and assist in tracking each revision through the approval workflow.
- Analyze existing procedures for concurrence with correct department methods and production records relative to company policies, governmental regulations, and license requirements. Specifically documents related to test specifications, technical documents, batch records, standard operating procedures, and forms.
- Write procedures with appropriate details that are easily understood and readily usable for consistency in training.
- Write procedures that reflect the most effective systems within company policies and government regulations to reduce misunderstanding and usability.
- Collects and analyzes the information necessary to complete the creation and revision for required documents.
- Initiates the necessary change controls to maintain compliance and revise existing documentation.
- Reviews the impact of the proposed changes with regards to other support documents.
- Determine if existing documentation/procedures are:
- Current and that there is consistency between similar documents.
- Meet internal control policies and regulations.
- Aligned with changes as required to current based on related investigations, audit responses, developmental, or compendia revisions.
- Required or redundant.
- Support the development of new and revised documents, including suggestions for suitable terminology, content, and format while ensuring that site policies comply with corporate guidelines.
- Participate in the review of Standard Operating Procedures, batch records, compound records, forms and other related GxP documents. Complete commitments as assigned to facilitate Corrective Actions/Preventative Actions.
- Assist in maintaining control of documentation to include accurate document history and change revision documentation.
- Bachelor’s degree in Science, Communications, or English, with at least 2 years related experience in technical writing, preferably in a pharmaceutical or related environment.
- AS in Communications or related field with minimum of 5 years related experience in technical writing, preferably in a Biopharmaceutical or other regulated environment.
- Understand pharmaceutical processes in order to design related documents.
- Able to edit documents quickly and efficiently to incorporate required revisions.
- Develops and applies standardized document formats where applicable.
- Able to learn and navigate document control and e-systems to facilitate document routing and approval.
- Able to effectively proofread documents prepared by self and others for content and others to ensure content and formatting accuracy.
- Able to write clearly and concisely with strong English background with excellent grammar, good writing skills and knowledge of sentence structure.
- Effective active listening skills. Able to translate verbal guidance into precise operating instructions.
- Adheres to and applies standard document formats while maintaining technical content of new and revised documents.
- Demonstrates an ability to adapt to shifting priorities, change, stress and to find appropriate balance between needs of the organization, others and self. Incorporates insights of other people into ongoing work.