Manager Analytical Development Jobs in Raleigh, NC

Job Description:

Is Kymanox the right fit for you?

You want to make a difference and have an impact...

You enjoy having an influence in your day-to-day work...

You are motivated by working alongside a team filled with

subject matter experts who will help you learn and grow...

You wake up every day and do what you do

... because patients deserve better.

If this sounds like you, you've come to the right place.

Responsibilities:

• Plans, designs, and executes laboratory formulation development activities across parenteral, nasal, pulmonary, and other routes of administration.
• Performs analytical development and testing, including chromatographic analysis by HPLC with UV and ELSD detection.
• Executes compendial and physicochemical testing, including viscosity, osmolality, pH, and particle size analysis.
• Develops, qualifies, and troubleshoots analytical methods in support of formulation and product characterization.
• Provides pharmaceutical consulting to clients in analytical chemistry and related CMC disciplines.
• Provides project leadership and support with supervision and guidance from managers as needed.
• Manages or provides oversight of third-party vendors (such as contract manufacturing organizations or analytical testing laboratories) as needed.
• Supports CMC activities such as batch manufacturing, release testing, and validation/qualification, as applicable.
• Maintains laboratory instrumentation and supports Lean Laboratory practices, instrument upkeep, and laboratory safety.
• Authors and reviews technically complex documentation, including protocols, methods, and reports, to ensure compliance with relevant standards and regulations.
• Participates in and supports a matrixed team environment with organized and detail-oriented initiatives.
• Follows policies or standard operating procedures to support internal or client projects.
• Completes assigned training requirements (internal and external).

Educational Background:

Experience:

• 7+ years' experience working in the pharmaceutical/drug, biotech/biologics, and/or combination product sectors is required.
• Hands-on analytical chemistry expertise, including chromatography (HPLC with UV and ELSD detection), is required.
• Expertise in compendial and physicochemical testing, including viscosity, osmolality, pH, and particle sizing, is required.
• Demonstrated formulation development experience in one or more routes of administration is required.
• Experience with parenteral, nasal, and/or pulmonary formulation and analytical development is strongly desired.
• Experience with combination products such as pre-filled syringes, autoinjectors, nasal devices, and pulmonary devices is desired.
• Experience with CMC processes, including batch manufacturing, release testing, and validation/qualification, is desired.
• Experience with Lean Laboratory principles, instrument maintenance, and laboratory safety is desired.
• Experience providing analytical chemistry consulting or client-facing technical services is desired.

Desired Aptitude and Skill Set:

• Detail-oriented
• Strong organizational skills and verbal/written communication skills
• Highly motivated self-starter with a sense of ownership and willingness to learn
• Thrive in a fast-paced, growing, and dynamic work environment
• Ability to form partnerships with internal stakeholders
• Seasoned soft skills (i.e., high EQ)
• Technology savvy

Travel:

Up to 10% travel is possible for support at tradeshows, conferences, and related events. A passport is required for this job.

Career Development:

The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.

Compensation:

Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process - as well as market conditions. Eligible for incentive program after 6 months of outstanding work.

Benefits:

Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.

About Kymanox:
Join Kymanox - a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today's biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox's service offerings and the life science industry as a whole.

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC.

To learn more about our company, please visit our website: Life Science Solutions | Kymanox

Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.