In labs and health care facilities worldwide -
HERE WE ARE
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
As a Senior Scientist, you will join the Process Analytics group to support process development and commercial manufacturing of biologics products. You will lead analytical support, including development, optimization and execution of quantitation and characterization assays.
The successful candidate will be a key contributor to a highly technical, diverse, and collaborative team of scientists and engineers within the Manufacturing Sciences and Technology group. You will contribute to cross-functional teams to meet highly visible business objectives. Deliverables include support of process development and robustness studies, process characterization, technology transfer and validation, high-throughput assay development, assay troubleshooting and technical leadership during interactions with stakeholders.
Additional responsibilities for the role on site at a major biopharmaceutical company:
- Lead the design and execution of experiments to qualify new assays for use on existing molecules and/or the adaptation of platform methods to new molecules
- Assess new technologies and evaluate their application to quantitation and characterization of product attributes and impurities
- Independently perform biophysical assay testing using established test methods, including associated protocol/report documentation and presentations
- Understand and apply advanced scientific principles, theories, concepts, practices and standards for method development
- Demonstrate independence in technique and method selection, data analysis and use of standard practices and procedures for problem solving
- Perform hands-on troubleshooting of a range biophysical characterization techniques, including HPLC/UPLC, CE, iCIEF and/or ELISA
- This position is based at the Devens site and may provide technical support to additional sites within the internal or external manufacturing network
- Author and review technical documentation, including testing protocols and reports
- Demonstrate a strong knowledge of cGMP compliance, customer corporate, site, and regulatory agency requirements and procedures.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.
Join PPD in our relentless pursuit of excellence - apply now!
Education and Experience:
- Bachelor's degree in Analytical Chemistry, Biochemistry or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- PhD, MS or BS in Analytical Chemistry, Biochemistry or related field with 0–2, 2-4 or 4 years, respectively, of relevant industrial and/or academic experience
- Previous experience in biotech or pharmaceutical industry and/or knowledge of FDA/ICH guidance is a plus
Knowledge, Skills and Abilities:
- Knowledge of protein chemistry and biology and standard methods of analysis of these molecules
- Technical expertise in HPLC, CE, iCIEF method development, validation and transfer
- Knowledge of theories, principles and techniques of relevant scientific areas and basic understanding of industry practices and standards
- Solid understanding and knowledge of general chemistry and separation science
- Ability to perform complex method development and suggest appropriate method modifications
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to prioritize work and experience in managing multiple projects in a fast-paced environment
- Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
- Critical qualities include a high degree of curiosity and initiative, good verbal and written communication skills and attention to detail
- Interpersonal and facilitation skills are necessary to interface with and influence across levels of the organization
- Ability to utilize Microsoft Excel and Word to perform tasks
- Proficiency on technical operating systems
- Proven problem solving and troubleshooting abilities
- Effective oral and written communication skills
- Proven ability in technical writing skills
- Ability to train junior staff
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform
successfully under pressure while prioritizing and handling multiple projects or
PPD Defining Principles:
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you