Product Technology Transfer Engineer

Company: Kelly Services
Location: Dickerson
Posted on: April 9, 2021

Job Description:

--Job Details: Industry:--------------------BiopharmaceuticalWork Location:-- Gaithersburg, MDJob Title:-------------------- Product Technology Transfer EngineerDuration:--------------------6 Months (Temporary/Contract)Kelly Services is currently seeking an Product Technology Transfer Engineer for one of our top clients in Gaithersburg, MD.--JOB DESCRIPTION:Candidates will be Remote however, may have to travel periodically (10-15%)Candidate should have a flexible working schedule and able to support other regions within the business.----- Note: The team will be based in the US East Coast, CMOs receiving technology transfers are located in EU, and Far East. Will require ability to work flexible hours to support multiple global time zones.We are looking to augment the GTO team working on technology transfers with a DS / DP Tech Transfer Engineer. In this role, you will also work with GTO Drug Substance and/or Drug Product technical stewards, R&D process development and quality experts and partner CMO sites to support ongoing technology transfers and process performance qualification at the CMO. You will be expected to stay on the program for a minimum of 6 months and up to 12 months.To succeed in this role, you will need to be self-motivated, well organized, have strong technical and communication skills, and a solid understanding and hands-on experience of biologics DS and/or DP manufacturing and quality/compliance requirements.The position provides the opportunity to work with a highly motivated and talented global team, working under aggressive timelines to deliver a cutting edge monoclonal antibody manufacturing process to multiple world-class manufacturing facilities and support efforts in dealing with the Covid-19 pandemic.Essential Job Functions:--- Work with Drug Substance/Drug Product Technical Stewards and SMEs from R&D, Quality, Validation and external partner sites to support technology transfer of drug substance processes (upstream and downstream) to external manufacturing sites.--- Support drafting, review and approval of tech transfer and manufacturing documentation such as risk assessments, gap analyses, batch records, standard operating procedures and sample plans.--- Serve as Manufacturing /Technical point of contact on specific workstreams/sub-projects, attending teleconferences with CMOS and internal teams, following up with stakeholders on action items etc.--- Update project dashboards/presentations with project status to provide timely communication of status to internal team. Proactively identify risks, and develop / implement work plans to manage / mitigate / communicate risk to senior technical transfer leads.--- Work with CMOs to compile and trend DS/DP manufacturing process data during manufacturing campaigns.Minimum Requirements:Education/Experience--- Degree in an engineering or scientific discipline with experience in biopharmaceutical Manufacturing Science& Technology/ Manufacturing/ Process Engineering/ Quality. Prior experience in Drug Substance tech transfers preferred.USP/DSP TT Lead ("reports" to DS TT Lead)o B.S with 6+ years of experienceo M.S. with 4+ years of experienceo PhD with 4+ years of experienceKnowledge/Skills--- Strong knowledge of biologics manufacturing operations and equipment, with prior experience in Manufacturing, Technical Operations, MFG Science and Technology, or Quality.--- Ability to work on multiple projects and meet deadlines as needed; emphasis on results-oriented, strong planning and execution skills--- Strong communication skills, with the ability to collaborate in cross functional teams across multiple organizations--- Ability to work in a complex, dynamic, global environmentWhy Kelly?As a Kelly Services employee, you will have access to numerous perks, including:

• Exposure to a variety of career opportunities as a result of our expansive network of client companies--
• Career guides, information and tools to help you successfully position yourself throughout every stage of your career
• Access to more than 3,000 online training courses through our Kelly Learning Center
• Weekly pay and service bonus plans
• Group-rate insurance options available immediately upon hire*Apply Today!--Why Kelly--?Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]]

Keywords: Kelly Services, Germantown , Product Technology Transfer Engineer, Other , Dickerson, Maryland