Research Scientist - Labs - Technology Transfer - Emerging Markets - in King of Prussia, PA
With 30 years of experience in the CRO/pharma industry and more than 18,500 employees worldwide, PPD's lab services units continue to flourish. PPD continues to recognize our employees as the cornerstone of our success and strive to provide a supportive environment that offers exciting opportunities for skills enhancement. Our cutting-edge technologies, real time analytics and superior training drive our employees to excel.
As such, PPD's Labs Managed Services group is growing rapidly. This group offers an exciting opportunity to work onsite with pharmaceutical/ biopharmaceutical companies, while maintaining full-time benefits/advantages of being a PPD employee.
Responsibilities for the role on site at a major pharma/biotech company:
This individual will be responsible for managing the analytical technology transfer for assigned projects from internal and/or external contract testing laboratories to importation testing laboratories in emerging markets including Asian Pacific and Latin American regions.
Specific responsibilities will include:
Responsible for all aspects of the analytical technology transfer process in alignment with quality work-processes;
Collect, verify and maintain the analytical related regulatory intelligence in emerging market space;
Critically evaluate and select testing laboratories;
Protocol generation, scheduling and executing of qualification and validation protocols;
Gathering and analyzing data, performing critical evaluations up to and including writing final analytical tech transfer report;
Own and manage method life cycles, and develop method qualification/validation strategies consistent with ICH requirements and current regulatory expectations;
Represent the team in multi-departmental project meetings and matrix teams;
Strong technical writing abilities and in depth knowledge of cGMPs, biopharmaceutical manufacturing processes, validation processes, and analytical methods is required;
Responsible for ensuring the relevant analytical sections of regulatory dossiers are authored and reviewed for quality and technical accuracy including compiling the responses associated any regulatory filings;
Lead and participate in internal/external audits and will be responsible for fronting the analytical/quality controls aspects associated with the projects;
Administer the critical reagents/reference standard inventory program and supports the effective transfer of analytical methods to and from sites;
Ensure budgetary forecasts associated with projects are tracked and managed;
IndeedPPDUS1
LI-SW1
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') or equivalent combination of education, training, & experience. OR
Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6 year)
OR
PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4 year)
Knowledge, Skills and Abilities:
Candidate must have a strong working technical and GMP knowledge in a biopharmaceutical quality control or development laboratory environment with experience in associated analytical methods (ELISA, cIEF, SDS-PAGE, SEC,CEX-HPLC, Immunoassay and Bioassay etc);
Work experience in method validation, technology transfer and stability testing in a GMP environment.
Strong project management skills, familiarity with project management tools such as Microsoft Project
Strong familiarity with FDA/EU/ICH and ROW regulations and guidance
Experience in CMC regulatory submission writing and review;
Excellent communication skill, ability to interact with both internal and external parties
Ability to work both independently and within a team environment;
Cold chain distribution and other logistics experience are highly desirable
Second language is a plus
Strong verbal, written and presentation skills
Superior time management, planning, and organizational skills
Proven analytical skills
Demonstrated compliance with procedures and policies
Ability to perform multiple tasks effectively in a stressful environment
Extensive knowledge and experience in Project Management
Strong client relationship management skills
Ability to work effectively with multi-level teams
Ability to work in a fast-paced undefined environment
Strong negotiation skills
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance.
Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
Full knowledge of technical operating systems
Ability to independently optimize analytical methods
Ability to independently perform root cause analysis for method investigations
Proven ability in technical writing skills
Proven problem solving and troubleshooting abilities
Effective written and oral communication skills as well as presentation skills
Time management and project management skills
Working Conditions
Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
Occasional drives to site locations, occasional domestic travel.
Exposure to biological fluids with potential exposure to infectious organisms.
Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
Personal protective equipment required such as protective eyewear, garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
Physical Requirements
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
Occasional mobility needed.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
As such, PPD's Labs Managed Services group is growing rapidly. This group offers an exciting opportunity to work onsite with pharmaceutical/ biopharmaceutical companies, while maintaining full-time benefits/advantages of being a PPD employee.
Responsibilities for the role on site at a major pharma/biotech company:
This individual will be responsible for managing the analytical technology transfer for assigned projects from internal and/or external contract testing laboratories to importation testing laboratories in emerging markets including Asian Pacific and Latin American regions.
Specific responsibilities will include:
Responsible for all aspects of the analytical technology transfer process in alignment with quality work-processes;
Collect, verify and maintain the analytical related regulatory intelligence in emerging market space;
Critically evaluate and select testing laboratories;
Protocol generation, scheduling and executing of qualification and validation protocols;
Gathering and analyzing data, performing critical evaluations up to and including writing final analytical tech transfer report;
Own and manage method life cycles, and develop method qualification/validation strategies consistent with ICH requirements and current regulatory expectations;
Represent the team in multi-departmental project meetings and matrix teams;
Strong technical writing abilities and in depth knowledge of cGMPs, biopharmaceutical manufacturing processes, validation processes, and analytical methods is required;
Responsible for ensuring the relevant analytical sections of regulatory dossiers are authored and reviewed for quality and technical accuracy including compiling the responses associated any regulatory filings;
Lead and participate in internal/external audits and will be responsible for fronting the analytical/quality controls aspects associated with the projects;
Administer the critical reagents/reference standard inventory program and supports the effective transfer of analytical methods to and from sites;
Ensure budgetary forecasts associated with projects are tracked and managed;
IndeedPPDUS1
LI-SW1
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') or equivalent combination of education, training, & experience. OR
Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6 year)
OR
PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4 year)
Knowledge, Skills and Abilities:
Candidate must have a strong working technical and GMP knowledge in a biopharmaceutical quality control or development laboratory environment with experience in associated analytical methods (ELISA, cIEF, SDS-PAGE, SEC,CEX-HPLC, Immunoassay and Bioassay etc);
Work experience in method validation, technology transfer and stability testing in a GMP environment.
Strong project management skills, familiarity with project management tools such as Microsoft Project
Strong familiarity with FDA/EU/ICH and ROW regulations and guidance
Experience in CMC regulatory submission writing and review;
Excellent communication skill, ability to interact with both internal and external parties
Ability to work both independently and within a team environment;
Cold chain distribution and other logistics experience are highly desirable
Second language is a plus
Strong verbal, written and presentation skills
Superior time management, planning, and organizational skills
Proven analytical skills
Demonstrated compliance with procedures and policies
Ability to perform multiple tasks effectively in a stressful environment
Extensive knowledge and experience in Project Management
Strong client relationship management skills
Ability to work effectively with multi-level teams
Ability to work in a fast-paced undefined environment
Strong negotiation skills
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance.
Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
Full knowledge of technical operating systems
Ability to independently optimize analytical methods
Ability to independently perform root cause analysis for method investigations
Proven ability in technical writing skills
Proven problem solving and troubleshooting abilities
Effective written and oral communication skills as well as presentation skills
Time management and project management skills
Working Conditions
Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
Occasional drives to site locations, occasional domestic travel.
Exposure to biological fluids with potential exposure to infectious organisms.
Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
Personal protective equipment required such as protective eyewear, garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
Physical Requirements
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
Occasional mobility needed.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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