Danaher Corporation Downstream Processing Manager - Viral vectors in Westborough, Massachusetts
The Accelerator Process Development group at Pall specializes in designing, optimizing and transferring scalable processes from pre-clinical to validated cGMP ready manufacturing.
This newly created position in our Process Development Team (PDS) will provide leadership and process development expertise for the development and scalability of viral vector and biologics related processes. This individual will lead or contribute to various cross functional teams ensuring a smooth technical transfer process from/to external sites on the behalf of our customers. The talent we seek has experience with downstream process development and scale up for viral vector or biologics production operations.
Essential Job Functions
Oversee the local Process Development Services operations for the downstream laboratory.
Primary technical point of contact within PDS
Oversee and lead activities related to Study plan generation, investigations, and resolution of complex technical issues.
Ensure well-organized, clear and complete documentations of all activities across all areas of responsibility.
Set clearly defined goals/objectives to ensure delivery of high-quality results.
You are passionate scientist focused on gene therapy or biologics-related downstream processes and equipment.
Experienced in tech transfer activities: ensuring sufficient quantities, quality, and timeliness of results are maintained.
The leader of technical investigations and risk assessments related with processes.
Oversee generation of SOPs, raw material specifications, master batch records and reports for tech transfer and development processes.
Perform independent data recording, analysis and troubleshooting.
Oversee document development work in concise reports and provide project updates in written and oral presentations
Lead and execute continuous process improvement activities aimed at providing robustness, capacity and productivity.
Maintain a high level of interaction and collaboration with the upstream and analytics teams.
Provide technical support, training and audits to internal and external collaborators.
Perform occasional extended hours and weekends to support ongoing lab activities as needed.
Q ua l i f ic a ti o n s/ E du c a t io n:
Bachelor’s degree with 10+ years of experience or higher education in biochemical engineering, molecular biology, biochemistry, or related scientific or engineering subject area with 5+ years of experience.
5 – 10 years in process development or clinical manufacturing laboratory setting with a focus on downstream process development, planning and execution of projects, tech transfer and process scalability. Downstream experience includes clarification unit operations, tangential flow filtration (TFF), chromatography and sterile filtration. Experience in managing technical teams and ability to lead innovation, change and drive for results. Ability to work in a Biosafety Level 2, follow safe lab procedures and maintain good laboratory practice (GLP).
Excellent written and verbal communication skills.
Ability to perform in a fast-paced environment.
Ability to work under minimal supervision and operate within a collaborative, team-oriented environment.
Strong analytical skills and attention to detail.
Strong facilitation skills to interface with all levels of the organization and build relationships.
Ability to plan and prioritize work to meet commitments aligned with organization goals.
Ability to deploy problem solving skills using rigorous logic and methods to solve difficult problems with effective solutions.
Where required: -
Lead investigations into nonperformance of new products
To enhance existing production methods
Appraisal/ mentoring of team members
Any other reasonable requests that make use of the job holder’s skills, experience and knowledge.
G ene r a l H ea l t h and S a f e t y :
T o f o ll ow r e l e v ant l e g al r e q u i r e m en t s and t he C o m pany H ea l t h & S a f e t y P o li c y
T o k eep y our w o r k a r ea ti dy and fr ee fr o m ha z a r ds
R epo r t and add r e ss any s a f e t y d e f ec t s .
To develop practices within the site that uphold and develop the principles of the Danaher-Pall Equal Employment Opportunities Policy. To work within and actively promote the Policy in relation to product/service delivery, training/development and staff management
The list of duties in the job description should not be regarded as exclusive or exhaustive. There will be other duties and requirements associated with your job and, in addition, as a term of your employment you may be required to undertake various other duties as may reasonably be required. Your duties will be as set out in the above job description but please note that Pall reserves the right to update your job description, from time to time, to reflect changes in, or to, your job. You will be consulted about any proposed changes.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.