The Process Development Scientist will be responsible for supporting the process development and optimization of downstream manufacturing processes for biologic production. This includes design and development of methods for biologic purification, scale-up processes, final formulation studies and testing of new technologies. This position will work cross functionally with all teams to develop and optimize techniques and manufacturing operations. The position requires excellent communication skills, a passion to learn and integrate knowledge across multiple aspects of drug development. The selected individual is expected to be a driven and creative self-starter who believes in team-based problem solving. The successful candidate is one who demonstrates excellence as a member of a highly collaborative team and who has a proven ability to execute and prioritize multiple experiments in parallel under minimal supervision. We are looking for a proactive, resourceful, and goal-oriented team member with a translational mindset and a do-what-it-takes attitude, who is able to work effectively both independently and as part of a matrixed project team.
• Set up, execute and monitor experiments related to process development • Design and execute experiments associated with scale-up production processes.
• Troubleshoot software or equipment malfunction as well as experiment errors and performs root-cause analyses to determine the source of error
• Provide technical guidance and assistance concerning technique and the use of equipment
• Manage multiple projects simultaneously with minimal supervision
• Assist in routine upstream bioprocess workflows that include media/buffer formulations and media changes. • Assist in established downstream bioprocess workflows and ensure compliance with established standards.
• Follow established standard operating procedures and complete required documentation following proper cGMP and GMP recording of entries in batch records, forms and protocols
• Maintain detailed records that are legible, accurate and readily understood.
• Work independently on specified tasks as defined by Supervisor. • Demonstrated professional and technical proficiency and an ability to communicate knowledge across multiple technical groups • May mentor, supervise (up to 3) and assist research staff. • Strong ability to analyze complex visual data in a quantitative and objective manner.
• Make decisions that impact a range of standard and non-standard operational, process, project activities within guidelines and policies.
• Serve as a key resource within a functional area or discipline
• Gain support for ideas or positions on difficult issues.
• Proactively seek to improve oneself and is recognized by peers and superiors as an emerging leader.
• Anticipate and solve complex problems
• Influence and impact across functional teams
• May lead medium-scale projects or programs with moderate risks and resource/financial requirements. May manage budgets for small to mid-sized projects
• Communicate and plans research material needs, plans and coordinates supply orders, and handles non-standard requests.
• Obtain quotes and negotiate pricing for bulk supply orders and equipment.
• Take initiative as problems and/or opportunities arise.
• Perform occasional work outside of the normal business hours, including weekend work.
• Safe handling, storage, and maintainance of chemicals according to Environmental Safety Division and OSHA regulations
Experience and qualifications:
• Expertise in biologic downstream purification processes such as common chromatography separation (affinity, ion exchange, mixed mode, hydrophobic interaction) and filtration methods. • Proficiency in biologic upstream processes including aseptic mammalian cell culture and harvest/recovery techniques • Excellent computer skills, including Microsoft Word, Excel and PowerPoint. • Proven ability to manage multiple projects while meeting high priority deadlines. • Demonstrated productivity and professionalism while working in a team environment and ability to coordinate activities across the team. • Demonstrated ability to work independently with limited supervision, demonstrating personal accountability • Demonstrated attention to detail and time management are essential along with strong written and verbal communication skills • Demonstrated excellent organization skills and ability to manage large amounts of technical data and documentation • Advanced ability to conduct literature searches on PubMed, Google Scholar, etc. • Proficiency with standard computer software as well as statistical software (JMP or GraphPad Prism) • Work experience in a GMP regulated environment within the Biotech/Pharma industry in a Process Development and/or Manufacturing Support role is preferred • Excellent written and oral communication skills • Demonstrated ability to work productively in a team environment is a must • Proven ability to multi-task and meet multiple high priority deadlines • Experience using Design of Experiments (DOE) and Quality by Design (QbD) methodologies Education: BS degree required in relevant field with 5-6 years direct and/or relevant experience will be preferred or MS degree in relevant field with 2 years experience desireable.
Qualified candidates submit a cover letter and resume to: email@example.com Subject line: Process Development Scientist - Downstream