Quality Control Chemist from Innova
Remote work, MA
About the Job
Innova Solutions has a client that is immediately hiring for Quality Control Chemist
Position type: Full-time Contract
Duration: 12 months Contract
Location: Remote
As a Quality Control Chemist, you will:
Key Responsibilities:
POSITION SUMMARY:
• Method Transfer Lead (MTL), Scientist, is a QC expert within the Development QC group. This individual contributor has good understanding of analytical method transfer and/or validation to ensure that method transfer and/or validation comply with cGMP and regulatory expectations.
POSITION RESPONSIBILITIES:
• Support Project Lead for method transfer and/or validation internally and externally for assigned program(s).
• Author or review protocols and reports for method transfer and/or method validation or method bridging, and other technical development reports associated with methods.
• Plan and track method transfer and/or method validation deliverables.
• Collaborate and interact with internal global QC testing sites/labs and external testing sites/labs, project leads and functional reps.
• Review method transfer and/or method validation assays, perform data verification, non-routine data mining, and in-depth data analysis
• Represent QC in intra-department project/initiative or cross-functional teams in support of program and company goals.
ORGANIZATIONAL RELATIONSHIPS:
• QC TT team
• QCSV-Portfolio
• PGS
• Analytical R&D
EDUCATION AND EXPERIENCE:
• Bachelor’s degree in life science (Post-graduate degree in a related field is a plus) in biology, biochemistry or any related technical discipline
• 8 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry and/or QC in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required
TECHNICAL SKILLS REQUIREMENTS:
• Expertise in designing and evaluating method validation and transfer studies including approaches such as partial re-validation, co-validation, and cross-validation.
• Technical writing skills for authoring methods, validation, and transfer studies/protocols/reports.
• Expert knowledge of scientific principles and expertise of mAb, ADC, vaccine, gene therapy, able to design and evaluate the design of study/experiment.
• Have good mindset and technical skills of analytical methods and plate-based method. Candidate with binding ELISA, cytotoxicity, resProA, res DNA and host cell protein method experiences are preferred but not required.
• Good project management skills and experience managing multiple projects at the same time is essential
• Possess strong data interpretation, method troubleshooting, skills and sounds scientific judgement
• Good time management skills with attention to detail and desire to achieve team and individual goals.
• Understand of regulatory guidance and requirements (ICH, CFR, general guidance) pertaining to method transfer and method validation, regulatory submission such as IND, IMPD, BLA or NDA, etc.
PHYSICAL POSITION REQUIREMENTS:
• Non-lab-based position.
Hard Skills:
1. Method Transfer Validation in QC
2. Protocols and Reporting
3. Good understanding of analytical and biochemical methodology
Preferred Skills:
1. Binding and Cell based assays
2. more than 8yrs experience
Suhail Ahmed
Email: Suhail.Ahmed@innovasolutions.com
Phone – 678-834-8320
PAY RANGE AND BENEFITS:
Pay Range*: $40 - $45 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws
''
Position type: Full-time Contract
Duration: 12 months Contract
Location: Remote
As a Quality Control Chemist, you will:
Key Responsibilities:
POSITION SUMMARY:
• Method Transfer Lead (MTL), Scientist, is a QC expert within the Development QC group. This individual contributor has good understanding of analytical method transfer and/or validation to ensure that method transfer and/or validation comply with cGMP and regulatory expectations.
POSITION RESPONSIBILITIES:
• Support Project Lead for method transfer and/or validation internally and externally for assigned program(s).
• Author or review protocols and reports for method transfer and/or method validation or method bridging, and other technical development reports associated with methods.
• Plan and track method transfer and/or method validation deliverables.
• Collaborate and interact with internal global QC testing sites/labs and external testing sites/labs, project leads and functional reps.
• Review method transfer and/or method validation assays, perform data verification, non-routine data mining, and in-depth data analysis
• Represent QC in intra-department project/initiative or cross-functional teams in support of program and company goals.
ORGANIZATIONAL RELATIONSHIPS:
• QC TT team
• QCSV-Portfolio
• PGS
• Analytical R&D
EDUCATION AND EXPERIENCE:
• Bachelor’s degree in life science (Post-graduate degree in a related field is a plus) in biology, biochemistry or any related technical discipline
• 8 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry and/or QC in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required
TECHNICAL SKILLS REQUIREMENTS:
• Expertise in designing and evaluating method validation and transfer studies including approaches such as partial re-validation, co-validation, and cross-validation.
• Technical writing skills for authoring methods, validation, and transfer studies/protocols/reports.
• Expert knowledge of scientific principles and expertise of mAb, ADC, vaccine, gene therapy, able to design and evaluate the design of study/experiment.
• Have good mindset and technical skills of analytical methods and plate-based method. Candidate with binding ELISA, cytotoxicity, resProA, res DNA and host cell protein method experiences are preferred but not required.
• Good project management skills and experience managing multiple projects at the same time is essential
• Possess strong data interpretation, method troubleshooting, skills and sounds scientific judgement
• Good time management skills with attention to detail and desire to achieve team and individual goals.
• Understand of regulatory guidance and requirements (ICH, CFR, general guidance) pertaining to method transfer and method validation, regulatory submission such as IND, IMPD, BLA or NDA, etc.
PHYSICAL POSITION REQUIREMENTS:
• Non-lab-based position.
Hard Skills:
1. Method Transfer Validation in QC
2. Protocols and Reporting
3. Good understanding of analytical and biochemical methodology
Preferred Skills:
1. Binding and Cell based assays
2. more than 8yrs experience
Suhail Ahmed
Email: Suhail.Ahmed@innovasolutions.com
Phone – 678-834-8320
PAY RANGE AND BENEFITS:
Pay Range*: $40 - $45 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:
- Named One of America’s Best Employers for New Grads by Forbes (2024
- Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List, 2024-2025)
- One of the Largest IT Staffing Firms in the US – Ranked #3 by Staffing Industry Analysts (SIA, 2024)
- One of the Largest Staffing Firms in the US – Ranked #13 by Staffing Industry Analysts (SIA, 2024; includes Innova Solutions, Volt, & HireGenics)
- Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
- One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC, 2024)
- AWS Advanced Tier Services Partner with 100+ certifications
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws
''
Salary
$40 - $45 per hour