PPD is a leading global contract research organization providing
comprehensive, integrated drug development, laboratory and lifecycle management services. 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.
The position will manage all aspects related to the commercial analytical method lifecycle for advancement of the pharmaceutical portfolio of products. This involves responsibility to develop and align analytical validation and technology transfer activities with project teams, analytical development, Quality and other key stake holders to ensure compliance with current regulatory standards. Key responsibilities are to enable the implementation of test methods in a QC environment for analysis of the physical and chemical properties of pharmaceutical materials (drug product, drug substance, raw materials etc.). The incumbent will provide their subject matter expertise to serve as a key partner in ensuring robustness of the methods, troubleshooting and triaging the methods throughout the product lifecycle.
• Prepare/review/approve protocols and reports for
analytical methods, their validation and technology transfer.
• As necessary, assist Client QC sites and TPMs with OOS investigation and troubleshooting.
• Resolve questions/ troubleshoot analytical techniques, procedures and validation requirements from BMS sites and third parties.
• Review method validation documentation to determine compliance with ICH requirements and manage remediation of gap analysis at TPM or in Client laboratories.
• Support Global Testing Standards group by reviewing change control documents, compendial monographs and proposed methods and specifications.
• Perform laboratory work to support product or process troubleshooting, special investigations and product complaints with limited supervision.
• Assist in the general operation of the analytical laboratory, including maintenance of Standard Operating Procedures (SOP’s), training and equipment validation or maintenance.
• Support the market life stability program by providing analytical expertise to perform analytical method troubleshooting and assist with OOS laboratory investigations at the Stability testing laboratory.
• Partner with External Manufacturing department to support all matters related to analytical method support at TPMs, including technology transfer, method troubleshooting and OOS laboratory investigations.
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
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 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.
Knowledge, Skills and Abilities:
- Full knowledge of technical operating systems
- Experience in Empower required.
- Experience in dissolution methods developing and testing, forced degradation studies and DOE support
- Extensive laboratory experience with and in-depth knowledge of conventional laboratory characterization techniques such as HPLC/UPLC, GC, dissolution, KF and wet chemistry is a must.
- Fluency in formulation development, pharmaceutical processing or pharmaceutical sciences is expected.
- Strong problem-solving and troubleshooting skills.
- Strong capabilities in experimental design and execution.
- Ability to work independently
- Familiar with USP and other compendia
- Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
- Ability to independently optimize analytical methods
- Ability to independently perform root cause analysis for method investigations
- Proven technical writing skills
- Effective written and oral communication skills as well as presentation skills
- Time management and project management skills
- Ability to mentor others on technical operating systems
- Ability to independently review and understand project proposals/plans
- Ability to work in a collaborative work environment with a team
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 activities.