Principal Analytical Method Development Chemist

Principal Analytical Method Development Chemist, Albuquerque, NM

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers therapies from curiosity to cure and ultimately to improve patients lives.

We proudly offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

Summary:

The Principal Analytical Method Development Chemist provides advanced technical leadership and scientific expertise in support of Manufacturing, Validation, Quality Control, and Engineering functions. This role is responsible for developing, optimizing, and implementing chemical processes for both new and existing pharmaceutical products within a CGMP environment. The Principal Process Chemist leads the introduction and scale-up of new products, ensures robust process design through data-driven strategies, and resolves complex technical challenges to improve yield, quality, and cost efficiency. The position also contributes to the creation and review of technical documentation, provides training and guidance to cross-functional teams, and supports regulatory compliance and safety initiatives across the site.

Essential Duties and Responsibilities:

• Execute projects independently. Document and report results according to approved procedures
• Develop and evaluate new chemical process technology and methods. Introduce, optimize, validate and support new processes into the laboratory.
• Develop strategies to optimize production processes with respect to yield, quality, throughput, and cost. Implement programs as required to optimize processes and resolve issues
• Provide technical coverage of new product introduction and commercial scale-up manufacturing as required
• Provide detailed instruction and/or training to site employees
• Write detailed records such as validation protocols and reports, method development protocols, etc., as required
• Supervise new product development and directly communicate with customers in consultation with Curia marketing team, project management team, and suppliers, to address technical issues
• Regularly communicate and present results of work performed in a clear, concise and accurate manner
• Prepare and review written instructions (batch records, methods, specifications, SOPs, protocols, etc.) to ensure that the products are made safely and tested under current good manufacturing practices (CGMPs)
• Maintain complete and up to date records per applicable procedures.
• Review proposed changes from a safety, practicality, feasibility, and CGMP perspective following Change Control procedures
• Perform laboratory experiments that are scientifically sound and generate valid data for making technologically sound decisions. Laboratory technique must be reproducible with no inherent bias
• Conduct all job responsibilities in a manner consistent with all applicable safety and environmental laws and regulations, company policies and procedures, site chemical hygiene plan, regulations, and commit to continuously improve safety and environmental performance
• Keep management up to date and informed of any significant results, events, or deviations from expected results, or work being conducted or envisioned that may impact safety, quality, or business
• Perform statistical evaluations of laboratory and data where required
• Assist in development of analytical methodology or standards for new or revised processes
• Assist Engineering, Maintenance, Production, and Validation departments with identification of equipment requirements (i.e., material of construction, etc.)
• Participate in monthly inspection of laboratory eyewashes, safety showers and/or fire extinguishers to ensure their operational status
• Store laboratory chemicals properly and in accordance with the chemical hygiene plan
• Participate as a chemistry subject matter expert in Process Hazards Analysis of processes to assure safe manufacturing process design
• Maintain a high level of knowledge of current Regulatory and requirements in addition to current scientific literature.
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Education and Experience:

• Bachelors degree in Chemistry or related Field
• Minimum of twelve (12) years relevant work experience
• Minimum of eight (8) years experience working with FDA, EPA, and OSHA regulated pharmaceuticals manufacturing requirements

Supervisory Responsibilities: This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.

Mathematical Skills: Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills: The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other Skills and Abilities:

• Provides guidance and mentorship to team members
• Fosters a collaborative and positive work environment
• Champions change
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail
• Broad knowledge of analytical chemistry methodologies in a GMP regulated industry with experience in method development and transfer in addition to full commercial product testing.
• Effective communication skills for preparation of written technical reports, presentations, SOPs, etc. Effective participation in meetings, problem solving exercises, etc.
• Ability to use basic computer software such as Microsoft Office Suite
• Ability to use and interpret data from modern analytical equipment such as NMR, HPLC, IR, etc.

Other Qualifications:

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each positions physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ear protection.

All environments may be subject to working with or being exposed to cleaning agents.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.