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Formulation Development Cmc Jobs in Minnesota (NOW HIRING)

Pace Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing ... May interpret analytical data to guide formulation and process development decisions. ESSENTIAL ...

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Formulation Development Cmc information

What is the salary of formulation R&D?

The salary for a Formulation Development CMC role typically ranges from $70,000 to $120,000 annually, depending on experience, education, and location. Entry-level positions may start lower, while experienced professionals with specialized skills can earn higher salaries, often supplemented with benefits and bonuses.

What is the highest paying job in pharmaceuticals?

In pharmaceuticals, senior roles such as Vice President of Research and Development or Chief Scientific Officer typically have the highest salaries, often exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and leadership skills in formulation development, CMC, and regulatory compliance.

What is the difference between Formulation Development Cmc vs Formulation Scientist?

AspectFormulation Development CmcFormulation Scientist
CredentialsBachelor's or Master's in Pharmacy, Chemistry, or related fields; industry certificationsBachelor's or Master's in Pharmaceutical Sciences, Chemistry, or related fields
Work EnvironmentPharmaceutical or biotech R&D labs, manufacturing settingsResearch labs, development facilities, pharmaceutical companies
Industry UsageRegulatory submissions, product development, manufacturing supportFormulation research, experimental design, product optimization

Formulation Development Cmc focuses on developing formulations suitable for regulatory approval and manufacturing, often involving documentation and compliance. Formulation Scientists primarily conduct research and experiments to create and optimize formulations. While both roles require similar educational backgrounds and work in related environments, Cmc roles emphasize regulatory and manufacturing aspects, whereas Scientists focus on experimental research and innovation.

Is formulation part of CMC?

In formulation development roles within CMC (Chemistry, Manufacturing, and Controls), formulation is a core component, involving the design and optimization of drug formulations to ensure stability, efficacy, and manufacturability. These professionals work closely with analytical, process development, and regulatory teams to develop suitable formulations for clinical and commercial products. Knowledge of formulation techniques, materials, and regulatory requirements is essential for success in this field.

What is Formulation Development CMC?

Formulation Development CMC (Chemistry, Manufacturing, and Controls) refers to the process of designing and optimizing the composition of a drug product, ensuring it is safe, effective, and stable for patient use. This role involves selecting appropriate excipients, developing the manufacturing process, and generating the data required to support regulatory submissions. CMC professionals collaborate with research, quality, and regulatory teams to ensure that the drug product meets all necessary standards throughout its lifecycle.

What are the key skills and qualifications needed to thrive as a Formulation Development CMC specialist, and why are they important?

To thrive as a Formulation Development CMC specialist, you need expertise in pharmaceutical sciences, chemistry, and regulatory guidelines, often supported by an advanced degree in a relevant field. Familiarity with analytical techniques, formulation equipment, and regulatory submission systems like eCTD is crucial. Strong problem-solving skills, attention to detail, and effective collaboration are essential soft skills in this role. These competencies ensure the successful development, optimization, and regulatory approval of safe and effective pharmaceutical products.

What are some typical challenges faced by professionals in Formulation Development CMC, and how are they addressed?

Professionals in Formulation Development CMC often encounter challenges such as ensuring formulation stability, meeting regulatory requirements, and scaling up from laboratory to manufacturing. Addressing these challenges requires close collaboration with analytical, regulatory, and manufacturing teams, as well as staying current with evolving guidelines. Effective project management, rigorous experimental design, and proactive risk assessment are key strategies to successfully navigate these complexities and ensure timely progress of drug development projects.

What jobs pay $2000 a day?

High-paying jobs that can reach $2000 a day often include specialized roles such as senior pharmaceutical formulation scientists, clinical trial consultants, or executive-level positions in the biotech and pharmaceutical industries. These roles typically require advanced degrees, extensive experience, and specialized skills in areas like formulation development, regulatory compliance, or project management.
What are popular job titles related to Formulation Development Cmc jobs in Minnesota? For Formulation Development Cmc jobs in Minnesota, the most frequently searched job titles are:

PLS Scientist I - BioPharma

Pacelabs

Oakdale, MN

$60K - $65K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted yesterday


Job description

Shift:

Monday through Friday, 8:30 AM - 5:00 PM

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

This is a full-time, onsite, Scientist 1 - Biopharma position located in Oakdale, MN,Monday through Friday, 8:30 a.m. - 5:00 p.m.

Compensation: $60,000 - $65,000 per year

The salary for this position reflects a variety of factors. Compensation will be determined based on the candidate's geographic location, relevant experience, education, skills, and alignment with internal equity. Market conditions, budgetary considerations, and organizational compensation guidelines may also influence the final offer.

Make an Impact. Build a Career.

Pace Life Sciences delivers a comprehensive suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Operating across a network of CDMO sites, GMP analytical testing laboratories, and manufacturing support centers, we partner with clients to efficiently advance programs from early development through commercialization.

Our experienced industry experts and continued investment in state-of-the-art facilities reflect our commitment to quality, speed, and reliability. United by a shared purpose, we bring meaningful value to patients, healthcare professionals, and health businesses worldwide by delivering services that support a safer, healthier future.

SUMMARY

Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. May design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. May interpret analytical data to guide formulation and process development decisions.

ESSENTIAL FUNCTIONS
  • Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing.

  • Provides complex to specialized review, analysis, interpretation, and documentation of testing results. Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.

  • Provides training and guidance on analytical tests, methods, and instrumentation, as required.

  • Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change.

  • Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.

  • Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients.

  • Develop validate and transfer analytical methods. Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, among others.

  • Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products.

  • Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards.

  • Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.

  • Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.

QUALIFICATIONS
Education and Experience
  • Bachelor's degree in chemistry/biochemistry, or a closely related field.

  • Two to three (2-3) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience.

Required Knowledge and Skills
Required Knowledge
  • Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development

  • Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures.

  • Complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns.

  • Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations.

  • Understanding of broad testing tools, equipment, and calibration.

  • Computer applications and systems related to the work.

  • Principles and practices to serving as an effective project team member.

  • Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.

  • Correct business English, including spelling, grammar, and punctuation.

Required Skills
  • Performing complex to specialized professional-level chemistry/biochemistry duties in a variety of assigned areas.

  • Overseeing and administering broad and varied chemistry/biochemistry/formulation functions.

  • Ability to operate and train others in analytical instruments and manufacturing equipment.

  • Training others in policies and procedures related to the work.

  • Serving as a team member and the development and management of projects.

  • Operating in a both a team and individual contributor environment.

  • Interpreting, applying, and explaining applicable laws, codes, and regulations.

  • Preparing very complex to specialized functionals reports, correspondence, and other written materials.

  • Using initiative and independent judgment within established department guidelines.

  • Using tact, discretion, and prudence in working with those contacted during the work.

  • Performing effective oral presentations to large and small groups across functional peers and the department.

  • Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.

  • Establishing and maintaining effective working relationships with a variety of individuals contacted in the course of the work.

PHYSICAL/MENTAL REQUIREMENTS

Work requires mobility in laboratory and office settings, use of standard equipment, and the ability to sit for extended periods. May require exerting up to 20 pounds occasionally and/or up to 10 pounds frequently to move objects. Requires vision to read materials and screens, and hearing and speech for communication in person and by phone.

WORKING ENVIRONMENT
Work is performed in both laboratory and office settings. Laboratory work may involve exposure to chemicals, fumes, gases, and related substances.

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits
When you join Pace, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes competitive salaries, medical, dental vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability and voluntary benefits, paid time off for holiday, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage and ID theft.

Equal Opportunity Employer

Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. 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.