Associate Chemist II

Bora Pharmaceuticals; Maple Grove (MN); On-site; USD 88,000 - 95,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Professional development

Job summary

Bora Pharmaceuticals in Maple Grove, MN, is seeking an Associate Chemist II to provide analytical support for new product development and perform testing per cGMP guidelines. You will document data, train others, and help improve analytical methods in a fast-paced lab environment.

Applicants should have a B.S. in Chemistry with 3+ years of pharmaceutical analytical experience and familiarity with HPLC, GC, titration, and dissolution testing.

Qualifications

• Bachelor's Degree in Chemistry or related field with 12 college chemistry credits and at least 3 years analytical experience.
• Knowledge of analytical chemistry and good verbal/written communication.

Responsibilities

• Reads, follows USP/NF, SOPs and study protocols.
• Documents results clearly per cGMP and SOPs.
• Performs analytical testing (e.g., dissolution, assay, impurities).
• Maintains instrument calibration and performs routine maintenance.
• Trains others on instruments or procedures.
• Participates in continuous improvement of laboratory operations.

Skills

Analytical chemistry

Independent work

Problem solving

Verbal & written communication

Troubleshooting

Education

Bachelor's degree in Chemistry

Tools

HPLC

GC

Titration

Dissolution

Job description

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.

From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora's teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.

At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer's success more certain.

Job Summary

The Associate Chemist II will provide analytical and technical support to new product development. Completes analytical testing method improvements and various laboratory support functions in a timely manner and according to cGMP's.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Essential Job Functions

• Reads, understands and follows the current USP/NF, laboratory SOPs, analytical methods and study protocols.
• Documents equipment usages and analytical results in a manner that can be readily followed by reviewers and is consistent with cGMP and in-house SOPs.
• Performs analytical testing according to established or preliminary methods such as cleaning validation samples, dissolutions, assay, impurities/degradation products, content/blend uniformity, pH, viscosity, titrations, general USP testing, residual solvents and other analytical methods.
• Documents with clear purposes, sequences and conclusions per GMPs. Takes ownership to assigned work and critically reviews it prior to distribution within the functional group.
• Serves as instrument or procedure trainer.
• Prioritizes assigned tasks and AIP goals based on work group needs with supervision. Is able to effectively plan work and utilize discretionary time so that assigned duties are completed in a timely manner.
• Reviews raw data timely and ensures it meets cGMPs and in-house SOPs, is scientifically sound and can be readily followed by auditors.
• Gathers source documentation or summary data required for regulatory submissions or technical reviews.
• Serves as instrument owner. Performs required functions including reviews and audits of instrument calibrations. Performs routine instrument maintenance and calibrations if needed.
• Maintains personal and shared workspace in an organized manner. Cleans laboratory glassware and actively participates in lab-wide routine clean up and inspection activities.
• Actively participates in continuous improvement efforts associated with laboratory operation.
• Works closely with supervisor or designee to complete assigned tasks and advance skills.
• Writes and/or updates analytical test methods and department SOPs. Assists with the implementation of new methods, instrumentation and new processes.
• Demonstrates cooperation and professionalism with all members of the Upsher-Smith organization. Addresses performance concerns in a timely and positive manner.
• Develops/validates methods such as cleaning verifications, water activity, particle size under the direction of the department management or designee. Writes validation protocols and reports.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience & Skills Required

• A Bachelor's Degree in Chemistry or related field with 12 credits of college chemistry, with a minimum of 3 years analytical experience, preferably in the pharmaceutical industry.
• Knowledge of analytical chemistry, good verbal and written communications skills.
• Ability to work independently, with others and to multitask. Working knowledge of HPLC, GC, titration, and dissolution with trouble shooting skills. Experience with PC's, cGMP's and USP testing.
• Good problem-solving skills.

Other Knowledge, Skills, and Abilities

• Ability to understand the concepts involved in various test procedures in order to evaluate the reliability of obtained results.
• Ability to write new procedures clearly and concisely which are easily understood.
• Good organizational and analytical skills.
• Computer skills and experience with related software.
• Conduct laboratory activities with forethought, control, consistency, respect for other's needs, and safe manner.
• Keeps personal workspace and shared instrument areas clean and organized.
• Ability to be flexible when changes associated project needs, directions, and processes occur without impacted in productivity and efficiency.

Compensation Range

$88,000 - $95,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.