What are the responsibilities and job description for the Biopharmaceuticals and Protein Chemistry Manager position at Kindeva Drug Delivery Careers?
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
The person hired for the position of Biopharmaceuticals and Protein Chemistry Manager will provide technical expertise and leadership in characterization and analysis of nucleic acids, proteins and peptides in drug products. The Biopharmaceuticals and Protein Chemistry Manager will be responsible for qualification of instrumentation, hiring and training of staff, method development and validation in adherence with cGMP requirements and regulatory standards. The Biopharmaceuticals and Protein Chemistry Manager will work closely with both internal and external clients to define testing needs and oversee execution of method development, validation and testing.
Job Responsibilities
California residents should review our Notice for California Employees and Applicants before applying.
The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
The person hired for the position of Biopharmaceuticals and Protein Chemistry Manager will provide technical expertise and leadership in characterization and analysis of nucleic acids, proteins and peptides in drug products. The Biopharmaceuticals and Protein Chemistry Manager will be responsible for qualification of instrumentation, hiring and training of staff, method development and validation in adherence with cGMP requirements and regulatory standards. The Biopharmaceuticals and Protein Chemistry Manager will work closely with both internal and external clients to define testing needs and oversee execution of method development, validation and testing.
Job Responsibilities
- Oversee, plan and execute nucleic acid, protein and peptide characterization testing within an analytical laboratory operating under cGMP conditions, ensuring compliance with all relevant regulatory standards and guidelines.
- Provide advanced technical support for the qualification, validation, and troubleshooting of testing equipment and methodology.
- Represent Kindeva externally as subject matter expert on nucleic acid, protein and peptide characterization through publications, presentations, industry working groups and other means.
- Author protocols and reports for complex method development, validation, and transfer for both internal and external clients.
- Assist in implementing testing solutions in collaboration with internal and external customers.
- Responsible for hiring and training of analytical chemists.
- Recommend instrument purchases based on market trend and opportunities that create value and growth opportunities for Kindeva.
- Manage timelines, budgets, resources, and hiring for ongoing and future projects.
- Document experiments, results, and findings in electronic laboratory notebook (ELN) and LIMS.
- Perform other duties as assigned.
- Bachelor’s degree or higher in a Science or a related discipline.
- Minimum 8 years’ hands on experience method development experience in protein and peptide characterization in a cGMP environment.
- Proficient in analytical techniques used to characterize both macromolecules and small molecules, such as chromatography, mass spectroscopy, electrophoresis, fluorescence, and protein characterization techniques.
- PhD in a Science discipline.
- Minimum 10 years’ hands-on method development experience in nucleic acid, protein and peptide characterization in a cGMP environment.
- Experience working with Electronic Laboratory Notebooks and LIMS.
- Past supervisory or leadership experience.
- Proficient in analytical techniques like chromatography, fluorescence, and protein characterization.
- Demonstrated ability to troubleshoot complex technical challenges and provide effective solutions.
- Excellent data analysis skills using DOE and statistics.
- Strong organizational and multi-tasking skills
- Excellent communications and interpersonal skills
- High attention to detail in developing and executing protocols, test methods, and associated documentation.
- Flexibility and adaptability to changing project requirements and timelines.
- Ability to work with cross-functional teams and external stakeholders to achieve project goals.
- Ability to act quickly and decisively.
California residents should review our Notice for California Employees and Applicants before applying.
The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
