Senior/Principal Consultant – Analytical & Formulation
Position Summary:
The Chemistry, Manufacturing & Controls area is responsible for developing, implementing, and directing regulatory, quality and technical strategies for new and mature products and interacting with regulatory agencies by providing strategic input, risk assessments and overseeing preparation of regulatory submissions.
Duties and Responsibilities:
- Serve as a regulatory, quality and technical CMC expert to clients.
- Advise on cGMP process and analytical development and validation, manufacturing, labelling and control of clinical development materials and commercial products.
- Advise on quality control and quality assurance systems and procedures required for cGMP manufacturing, testing, control and release to clinic or market.
- Provide advice and auditing for analytical and manufacturing activities for ensuring cGMP compliance and readiness.
- Advise on testing and manufacturing site identification, design and build-out for cGMP activities, including site validation and commissioning.
- Advise on and provide direct support for CMC regulatory activities, development plans and dossiers for investigational new drugs, clinical trial applications, biologics licensing applications and new drug applications.
- Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
- Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biopharmaceutical, drug and combination products, to expedite submission, review and approval of CMC applications.
- Represents CMC RA in project team meetings and provides regulatory guidance and perspective to the cross-functional team.
- Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements.
- Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and standard guidelines
- Ensures all appropriate strategic CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
- Has accountability for information submitted in marketing applications to meet client requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability.
- Provide due diligence advice and auditing for legal and/or M&A requests.
- Provide legal expert advice.
- Represent Personal Expertise and Company in Publications, Social Media Platforms, and/or Industry or Government Meetings.
- Opportunities to participate in the entire development plan builds from pre-IND, IND, NDA and commercialization.
- Opportunity to serve on cross-functional teams that include nonclinical, clinical, regulatory affairs and operations.
- Stays abreast of changing trends and current events within the industry.
- Subject matter expert in technical, quality and regulatory aspects of CMC.
- Leading and influencing frequent interactions for client pre-submission, submission and post-submission activities with regulatory authorities.
- Directs project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable. Provides strategic direction, data assessment and conclusions to senior management.
- Leads client meetings and conducts client liaison on an ongoing basis.
- Provides scientific insight for new business pitches and proposals.
- Proactively identify new regulatory trends and challenges and predict the effect on regulations policies and procedures.
- Formulates novel approaches and influences people, systems, and processes.
- Identifies key risks to the business associated with submission data and information packages and provides and communicates to senior management well defined risk mitigation strategies.
- Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies, and systems.
- Builds collaborative relationships with stakeholders and manage the internal and external teams responsible for delivery and develop junior team members
- Having an intuition for the needs of the client and the ability to adjust to those needs.
- Ability to work within deadlines and solve challenges in a pragmatic and proactive manner.
- Ability to dig into the details while keeping an eye on the overall goal of the project.
- Must be organized, proactive and self-motivated individual with a keen eye for detail, ability to prioritize tasks effectively and ability to effectively delegate to team members.
- Keen consultancy skills in handling clients gained through direct experience in a client-facing role.
- Skilled in human interactions within multicultural teams, including the ability to challenge other experts when deemed necessary.
- Previous experience leading people, functions and/or projects.
- Ability to work independently and pro-actively lead a project team.
- Ability to create effective PowerPoint presentations.
Anticipated travel requirements for the position will be approximately 20% based on client requirements. This is a ‘remote work’ position however, the incumbent will be required to travel to Alexandria, VA headquarters up to twice per year for team meetings.
Qualifications:
- Terminal degree required in one of the following or related areas: Biochemistry, Biotechnology, Molecular Biology, Biotechnology Engineering, Biology, Chemistry, Pharmaceutical Sciences, or other related fields. (PHD preferred)
- RAC certification a plus, but not required.
- 10+years (Senior) or 15+ years (Principal) CMC experience in process or analytical development and/or QA/QC with regulatory experience in the pharmaceutical, biologics or combination product industry, with a history of successful investigational new drug and/or marketing dossier submissions.
- Subject matter expert in CMC process, analytics, and/or quality, with CMC regulatory experience.
- Excellent verbal and written communication skills.
- Excellent soft skills in cross-functional management and client relation interactions.
- Must exercise rapid learning ability, attention to detail, excellent computer skills, excellent oral and written communication skills, team player, organized analytical thinker with a high level of energy and self-motivation.
- Demonstrated versatility in conflict resolution, problem solving, and working effectively as a part of a cross functional organization.
- Demonstrated focus in exceeding client expectations.
- Ability to manage organizational change.
- Comprehensive knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products
- Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues
- Comprehensive knowledge and experience in preparing Quality CMC sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA
- Experience creating Regulatory strategy and executing on those plans.
- Direct consulting experience in regulatory affairs, industry and/or regulatory authorities specifically in the CMC industry.
Essential Skills:
- Proficient in Microsoft Office Suite, keyboard skills, oral and written communications skills, strong documentation skills, math aptitude, diplomacy and leadership skills, professionalism, time management, ability to multi-task, able to work independently, able to maintain confidentiality.
The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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