Research Scientist - Tech Transfer - Emerging Markets

Submission for the position: Research Scientist - Tech Transfer - Emerging Markets - (Job Number: 167890)

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.

The Research Scientist positionconducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports.

For this position you would develop strategy and provide analytical support to registration/launch of biopharm products in Emerging Markets – including technical evaluation/selection of lab, coordination and managing projects, analytical tech transfer, sample/reagents request, logistics and procurement.

Key Responsibilities:

•Playing role of point of contact and project manager for analytical technology transfer to Emerging Market (EM) countries.

•Lead analytical activities for biopharm product launch in EM countries including sample/reagent management, cold chain management, analytical tech transfer and documentation support.

•Lead analytical sub-team; provide insights and issues related to the analytical, QC, sample/reagents request and supply to support registration in Emerging Markets.

•Authors and coordinate the execution of method transfer protocols, reports and other documentation related to the Emerging Markets analytical activities.

•Work closely within and across functional matrix teams to ensure harmonization of release, stability and technology transfer testing practices.

•Participate in successful and timely transfer of analytical technologies of other biopharm assets to and from various R&D departments, Client commercial manufacturing organizations or contract manufacturers’ testing labs.

•Collaborate with Client analytical development groups and serve as a liaison on technical issues with secondary customers.

•Work with QA, document control and validation groups to ensure quality standards are maintained and/ or enhanced.

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.

Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader -- these are just a few career pathways available once your become a part of the PPD team.

To learn how PPD can advance your career, apply now!

What To Expect NextWe look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

PPDFSP

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.

The Research Scientist positionconducts and provides technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR performs troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports.

For this position you would develop strategy and provide analytical support to registration/launch of biopharm products in Emerging Markets – including technical evaluation/selection of lab, coordination and managing projects, analytical tech transfer, sample/reagents request, logistics and procurement.

Key Responsibilities:

•Playing role of point of contact and project manager for analytical technology transfer to Emerging Market (EM) countries.

•Lead analytical activities for biopharm product launch in EM countries including sample/reagent management, cold chain management, analytical tech transfer and documentation support.

•Lead analytical sub-team; provide insights and issues related to the analytical, QC, sample/reagents request and supply to support registration in Emerging Markets.

•Authors and coordinate the execution of method transfer protocols, reports and other documentation related to the Emerging Markets analytical activities.

•Work closely within and across functional matrix teams to ensure harmonization of release, stability and technology transfer testing practices.

•Participate in successful and timely transfer of analytical technologies of other biopharm assets to and from various R&D departments, Client commercial manufacturing organizations or contract manufacturers’ testing labs.

•Collaborate with Client analytical development groups and serve as a liaison on technical issues with secondary customers.

•Work with QA, document control and validation groups to ensure quality standards are maintained and/ or enhanced.

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.

Our teams support career growth whether you are looking for long term opportunities within the scientific ladder, to pursue project management, or develop into a leader -- these are just a few career pathways available once your become a part of the PPD team.

To learn how PPD can advance your career, apply now!

What To Expect NextWe look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

PPDFSP

Qualifications

Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years).Knowledge, Skills and Abilities:Extensive industrial working experience in analytical development to support pharmaceutical developmental projects; in working in a cross-functional multi-disciplinary team; in project transfer, technology transfer and analytical transfer, 3rd party service providers and business alliance partners.Comprehensive hands-on experience in analytical instrumentation; research and methods development/validation/transfer, setting specifications, release and stability testing in support of clinical projects and commercial products.

Preparation, review and approval of developmental technical documents, policies and procedures.Skills in collaboration, interaction with people of different background, alliance formation, agreement negotiation, team-building.Proficient with MS Office Suite (Word, Excel, PowerPoint)

Thorough knowledge of cGMP requirements and at least one year of industry experience in a cGMP regulated lab.Previous experience in Analytical Technology Transfer and ValidationFamiliarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Release and Stability Testing, Product Characterization, and Comparability Assessment.Independently applies knowledge in area of specialization to assignments that involve multiple decision points.Familiar with GLP regulations.Previous Biopharmaceutical experience is required.

Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidanceFull knowledge of technical operating systemsAbility to independently optimize analytical methodsAbility to independently perform root cause analysis for method investigationsProven technical writing skillsProven problem solving and troubleshooting abilitiesEffective written and oral communication skills as well as presentation skillsTime management and project management skillsAbility to mentor others on technical operating systemsAbility to independently review and understand project proposals/plansAbility 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 mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements typically found in healthcare of laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesQualifications

Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years).Knowledge, Skills and Abilities:Extensive industrial working experience in analytical development to support pharmaceutical developmental projects; in working in a cross-functional multi-disciplinary team; in project transfer, technology transfer and analytical transfer, 3rd party service providers and business alliance partners.Comprehensive hands-on experience in analytical instrumentation; research and methods development/validation/transfer, setting specifications, release and stability testing in support of clinical projects and commercial products.

Preparation, review and approval of developmental technical documents, policies and procedures.Skills in collaboration, interaction with people of different background, alliance formation, agreement negotiation, team-building.Proficient with MS Office Suite (Word, Excel, PowerPoint)

Thorough knowledge of cGMP requirements and at least one year of industry experience in a cGMP regulated lab.Previous experience in Analytical Technology Transfer and ValidationFamiliarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Release and Stability Testing, Product Characterization, and Comparability Assessment.Independently applies knowledge in area of specialization to assignments that involve multiple decision points.Familiar with GLP regulations.Previous Biopharmaceutical experience is required.

Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidanceFull knowledge of technical operating systemsAbility to independently optimize analytical methodsAbility to independently perform root cause analysis for method investigationsProven technical writing skillsProven problem solving and troubleshooting abilitiesEffective written and oral communication skills as well as presentation skillsTime management and project management skillsAbility to mentor others on technical operating systemsAbility to independently review and understand project proposals/plansAbility 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 mannerAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 poundsAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyMay have exposure to potentially hazardous elements typically found in healthcare of laboratory environmentsAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesSubmission for the position: Research Scientist - Tech Transfer - Emerging Markets - (Job Number: 167890)