Consultant/Biologics (Individual Contributor Role)

This is a remote position.

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us atwww.pharmavise.com

We are excited to announce an opportunity for a talented and experienced professional to join our team as a Consultant/Biologics. Below is a detailed job description outlining the responsibilities, qualifications, and expectations for this individual contributor role:

Responsibilities:

1. Provide expert consulting services and strategic advice to clients in the biopharmaceutical industry, with a focus on biologics development, manufacturing, and regulatory affairs.

2. Collaborate closely with clients to understand their needs, challenges, and objectives, and develop tailored solutions to address specific business and regulatory requirements.

3. Conduct assessments and gap analyses of clients' biologics programs, processes, and operations to identify areas for improvement and optimization.

4. Develop and implement strategic plans and initiatives to support clients' biologics development and commercialization efforts, including regulatory strategy, CMC (Chemistry, Manufacturing, and Controls) strategy, and lifecycle management.

5. Provide guidance and support on regulatory submissions for biologic products, including INDs, BLAs, MAAs, variations, and post-approval supplements.

6. Review and interpret regulatory guidelines, requirements, and industry best practices related to biologics development, manufacturing, and compliance.

7. Support clients in preparing for regulatory interactions and inspections, including FDA meetings, regulatory agency audits, and responses to regulatory inquiries.

8. Stay abreast of emerging trends, advancements, and regulatory changes in the biologics industry and provide insights and recommendations to clients.

Qualifications:

1. Advanced degree (PhD, MS, or equivalent) in a scientific or engineering discipline, preferably in biochemistry, biotechnology, pharmaceutical sciences, or related field.

2. Minimum of 5 years of experience in the biopharmaceutical industry, with a focus on biologics development, manufacturing, or regulatory affairs.

3. Strong expertise in biologics development and manufacturing processes, including upstream and downstream processing, analytical methods, and characterization techniques.

4. Deep understanding of global regulatory requirements and guidelines applicable to biologic products, including FDA, EMA, and ICH regulations.

5. Proven track record of successful consulting engagements or project management in the biopharmaceutical industry, with demonstrated ability to deliver results and drive client satisfaction.

6. Excellent communication and interpersonal skills, with the ability to effectively engage with clients at all levels of the organization.

7. Strong analytical and problem-solving abilities, with the ability to assess complex challenges and develop innovative solutions.

8. Willingness to travel as needed to meet client requirements.

This is an exciting opportunity to join a dynamic and growing consulting team focused on supporting clients in the biopharmaceutical industry. Competitive compensation packages are available.

EEO Employer:

PharmaviseConsulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.PharmaviseConsulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contactinfo@pharmavise.com.

PharmaviseConsulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you joinPharmavise, you become part of a team that values Excellence Through Quality.