Operations – Manufacturing /
Full-time Exempt /
At Serán, we utilize a science-first methodology and cutting-edge technologies to enable our healthcare customers to discover and develop innovative medicines that improve patient health.
The Technical Writer is responsible for creating a variety of manufacturing documents that meet the highest technical and compliance standards while directly contributing to the overall success of client’s drug products and programs. This position requires coordination with multiple internal teams and subject matter experts (e.g. Operations, R&D, Project Management, Quality Control, and Quality Assurance) to ensure all necessary documentation for a project is accurate and approved prior to execution of a manufacturing campaign. The ideal candidate will possess a strong attention to detail, the ability to collaborate across teams with the ability to work in a fast-paced, dynamic CDMO setting.
- Interview and train new staff
- Oversee daily workflow of the department
- Provide constructive feedback on peers’ work
- Perform other related duties as assigned
Duties and Responsibilities
- Manage the entire document lifecycle from drafting through review and approval for assigned documents (e.g. Master Batch Records (MBRs), GMP Campaign Summary Reports, Incident Reports (IRs), Corrective and Preventative Action Plans (CAPAs))
- Interface directly with client technical and quality teams during drafting of documents
- Support comment response resolution during document drafting stage
- Identify and escalate obstacles to management to allow proper resolution prior to deadlines
- Support other ongoing activities of the Technology Transfer group
Required Skills and Abilities
- Excellent verbal and written communication skills
- Excellent interpersonal and customer service skills
- Excellent organizational skills and attention to detail
- Excellent time management skills with a proven ability to meet deadlines
- Strong analytical and problem-solving skills
- Ability to prioritize tasks and to delegate them when appropriate
- Ability to function well in a high-paced and at times stressful environment
- Proficient with Microsoft Office Suite or related software
Education and Experience
- High school diploma or equivalent with Bachelor’s degree in a scientific field preferred
- At least one year of experience working in a client-facing administrative role
- 2+ years GMP experience required
- Prolonged periods of sitting at a desk and working on a computer
Compensation correlates to skills and experience presented by selected candidate. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs. Serán fully funds employees and their household with dental, vision and one medical plan option. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing.