Solid Form Scientist

Company Description

We are a global leader in the development and manufacturing of active pharmaceutical ingredients, focused on specialist niches with expertise in highly regulated and complex chemistries. Formerly part of Johnson Matthey, we have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle.

Job Description

With a degree of independence, design, develop and optimize scalable crystallization processes of Active Pharmaceutical Ingredients (APIs) and intermediates ensuring the correct crystalline form can be scaled-up. This encompasses Veranova’s activities in Solid Form (Polymorph) Screening, Salt Selection, Co-Crystal Screening, Physical Form Characterization and Crystal / Particle Engineering. Plan and execute experiments and research on intermediates and APIs using process and research development methodologies. Serves as the technical lead on projects and provides direction to various levels of chemist and scientist. Deliver projects on target with quantity, quality, time, and within budget.

PRINCIPAL ACCOUNTABILITIES

• With input from the project team, design appropriate plans to meet project goals within the required timeline and budget.
• Develops and plans efficient and timely projects. Project plans and objectives are continually assessed relative to the scope of the project.
• Independently evaluates scientific techniques and procedures for solving problems based on literature research and consultation with scientific peers.
• Perform laboratory experiments to develop new methods for the efficient, economical, and safe crystallization production of pharmaceutical intermediates and products.
• Test new theories to solve important problems within the scope of client projects.
• Execute projects culminating in definite scientific conclusions.
• Document scientific procedures and results in lab notebooks, or other designated forms.
• Generate written progress reports and present scientific results to team members.
• Plan, execute and summarize GMP and non GMP processes to support projects.
• Mentors, leads, and advises junior chemists in areas of scientific, regulatory, project management, client, and safety issues and helps develop project and career objectives.
• Multi-task responsibilities including laboratory work, preparing scientific reports and documents, presenting scientific findings to teams and clients, and using scientific literature to solve advanced technical problems and develop new techniques.
• Learn technical proficiency, think independently, exercise sound judgments that correspond with experience, and adhere to safe work practices.
• Also performs additional scientific tasks with a higher level of independence such as:
• Emphasis on continuous learning and growth in new scientific fields and/or improving level of competency in major field of expertise.
• Evaluates potential new projects, clients, and techniques.
• Other duties as assigned.

QUALITY/REGULATORY RESPONSIBILITIES

• Demonstrates technical proficiency and self-assuredness in applying cGMP standards.
• Applies cGMP concepts in association with department specific responsibilities.
• Ensures all documentation produced is in compliance with cGMP standards.
• Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
• Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.

ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBILITIES

• Follows and abides by all EH&S policies, practices, and procedures in association with department specific responsibilities.
• Demonstrates technical and procedural proficiency and self-assuredness in applying EH&S standards.
• Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers.
• Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated.
• Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.
• Support the Company’s commitment for environmental health & safety by applying ISO 14001, OHSAS 18001, and Sustainability 2017 principals into daily activities.

PHYSICAL DEMANDS & WORK ENVIRONMENT

• While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
• Must be able to lift and/or move up to 50 pounds.
• Specific vision abilities include: near, distance, peripheral, color perception, and the ability to adjust focus.
• Regularly works with moving mechanical parts and may work with toxic or caustic chemicals. The work may be performed in humid areas with low or high temperatures.

Qualifications

ESSENTIAL

• PhD in Chemistry or equivalent with a minimum of 2-5 years related experience in a pharmaceutical industry
• MS in Chemistry or equivalent with a minimum of 5-9 years related experience in a pharmaceutical industry
• BS in Chemistry or equivalent with a minimum of 8-12 years related experience in a pharmaceutical industry
• Minimum of 2 years of technical experience and understanding process and research development of APIs
• Experienced in developing and optimizing crystallization routes, producing and/or scaling up intermediates and API process development for polymorphs, salts and co-crystals
• Understanding of crystallization science, crystal engineering and the solid state (chemistry and physics) of APIs
• Ability to successfully work independently and with interdepartmental teams
• Ability to lead projects and provide direction to various levels of Scientist and/or Chemist
• Ability to plan, organize, and oversee multiple independent development or production programs
• Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents
• Ability to define problems, collect data, recognize patterns, and draw conclusions from disparate information streams
• Knowledge and preferentially hands-on experience with Solid Forms characterization techniques (XRPD, DSC, TGA, microscopy, DVS)
• Knowledge/awareness of broader analytical techniques (HPLC, LC-MS GC, NMR, UV, KF)
• Experienced in communicating effectively to project teams and management
• Ability to write clear and concise technical reports, business correspondence and procedure manuals
• Strong written and verbal communication and presentation skills
• Demonstrate ability to exercise good judgment and make decisions in a timely manner
• Awareness of Quality Sytems; GMP, GLP
• Extensive knowledge of Microsoft Office

VALUED

• Appreciation and knowledge of chemical engineering principles and how to apply them to process scale up.
• Knowledge of mixing and crystallization modeling to support successful scale up.
• Knowledge and experience of process analytical technologies for chemical and crystallization processes.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state or local law.

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