Quality Control (QC) Analyst I, II, & III

Description

Company Overview

Creating a Healthier World through Accessible Biologics:

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC, in the United States, and its subsidiary, Kashiv BioSciences Private Limited, in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

Position Summary

The Quality Control Analyst will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required.

Essential Duties & Responsibilities

• Analytical testing to support product in-process, release, and stability programs.
• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
• Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.
• Work with cross-functional teams to advance projects, maintain equipment, and author documents and reports.
• Performs other functions as required or assigned
• Complies with all company policies and standards

Requirements

Position Requirements and Qualifications

Minimum Qualifications:

Education:

• A 4-year Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field 

Experience:

• Previous experience for QC I (0 to 2 years or more), QC II (2 to 5 years or more), and QC III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required.
• Working knowledge of cGMP regulations (21 CFR210/211/820) is required.
• Strong background in small molecule and protein chemistry and experience in troubleshooting analytical results.
• Demonstrated success at writing, revising, and complying with SOPs, policies, and QC methods.

Preferred Qualifications: 

SPECIALIZED KNOWLEDGE AND SKILLS: 

QC I & II Analyst

• Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. 
• Previous experience supporting regulatory inspections (e.g., PAI).
• Familiarity with preparing regulatory dossiers and data packages for interactions between Kashiv and regulatory agencies.

QC III Analyst

• In-depth understanding and technical knowledge of the analytical methods such as UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA performed under QC laboratory environment, and be familiar with all basic and some complex laboratory equipment/instrumentation.
• Strong communication skills, both written and verbal.
• Must be detail-oriented.
• Must be able to effectively manage time to complete assignments. 
• Excellent computer skills in Microsoft Office applications

Compensation:

• QC I Analyst – Base Salary Range and Yearly Bonus (0–2 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $70,000 to $75,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus
• QC II Analyst - Base Salary Range and Yearly Bonus (2-5 years or more of manufacturing biologics/biosimilars Quality Assurance experience) - $80,000 to $85,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus
• QC III Analyst - Base Salary Range and Yearly Bonus (5 plus years or more of manufacturing biologics/biosimilars Quality Assurance Analyst experience) - $90,000 to $95,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus

Benefits/Perks:

• Medical Insurance - Aetna
  • Prescription Drug Converge | Rx
  • Virtual Visits - Aetna/Teladoc
  • Health Savings Accounts (HSA)
  • Flexible Spending Accounts (FSA)
• Dental Insurance - Aetna
• Vision Insurance - VSP
• Life and AD&D Insurance
• Disability Benefits
• Supplemental Benefits
  • Legal Services
  • ID Theft Protection
  • Travel Assistance
• Value Added Benefits & Services
  • Health Advocate
  • Life Assistance Program (LAP)
  • Student Loan Assistance Program
• 401K
• Monthly Cell Phone Allowance

Hours:

This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

• Typing, desk work,  and plant auditing.
• Must be able to read, write, and understand English.
• Manufacturing clean rooms. Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
• Safety alertness is required due to working around hazardous equipment and conditions.

· General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines.

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties, or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.