Director of Pharmaceutical Sciences and Product Development

McGuff Pharmaceuticals Inc. is seeking an experienced pharmaceutical development leader who combines scientific expertise, regulatory knowledge, business judgment, commercial awareness, and organizational leadership.

This role is responsible not only for product development execution but also for helping shape the future product portfolio of the company. The successful candidate will play a key role in identifying, evaluating, prioritizing, and commercializing new product opportunities.

The ideal candidate has successfully built or significantly expanded pharmaceutical development organizations and understands how to identify, evaluate, prioritize, develop, transfer, and commercialize pharmaceutical products.

We are particularly interested in candidates who have succeeded in entrepreneurial pharmaceutical organizations where resources must be allocated thoughtfully and efficiently.

Key Responsibilities

Department Leadership

• Build and lead the Product Development Department.

• Develop and implement product development policies, procedures, governance systems, and stage-gate processes.

• Establish development systems, project management tools, KPIs, and portfolio management processes.

• Recruit, mentor, and develop scientific and technical staff.

• Develop organizational capabilities that support future company growth.

• Build a department capable of supporting multiple simultaneous pharmaceutical development programs.

Product Development

• Lead development of sterile pharmaceutical products from concept through commercialization.

• Direct formulation, analytical, stability, process development, validation support, and technology transfer activities.

• Manage multiple development programs simultaneously.

• Ensure development activities align with regulatory and commercial objectives.

• Support future expansion into additional dosage forms and pharmaceutical product categories.

Regulatory and CMC Strategy

• Develop regulatory strategies for ANDA, 505(b)(2), and related pathways.

• Lead CMC planning and execution activities.

• Work closely with Regulatory Affairs and Quality organizations.

• Support FDA interactions and regulatory submissions as appropriate.

• Ensure development activities are aligned with current FDA expectations and industry best practices.

Portfolio Development and Opportunity Assessment

• Evaluate and prioritize product opportunities based on technical, regulatory, manufacturing, commercial, and strategic considerations.

• Identify future product opportunities including:

• Drug shortage products

• Hospital products

• Generic opportunities

• 503B market opportunities

• Specialty pharmaceutical opportunities aligned with company capabilities

• Develop long-term product pipeline strategies supporting company growth.

• Recommend product investment priorities and portfolio decisions to executive leadership.

External Resource Management

• Manage CROs, consultants, analytical laboratories, and development partners.

• Determine which activities should be maintained internally versus outsourced.

• Establish and manage strategic external development relationships.

• Ensure effective utilization of external resources while maintaining internal technical expertise.

Technology Transfer

• Lead successful transfer of products from development through commercial manufacturing.

• Work closely with Manufacturing, Engineering, Quality, and Regulatory teams to ensure successful commercialization.

• Establish scalable development processes that support future manufacturing growth.

• Develop systems that facilitate efficient transfer from development to commercial operations.

Required Qualifications

• Advanced degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, Chemical Engineering, or related scientific discipline.

• Typically 10+ years of relevant pharmaceutical product development experience, including demonstrated success leading development programs, teams, and commercialization activities.

• Demonstrated success developing and commercializing sterile pharmaceutical products.

• Experience leading multiple development programs simultaneously.

• Strong understanding of FDA expectations for sterile drug products.

• Working knowledge of:

o ANDA pathways

o 505(b)(2) opportunities

o CMC strategy

o Stability programs

o Validation requirements

o Technology transfer

• Experience managing CROs, consultants, and external development partners.

• Strong leadership and organizational development skills.

Strongly Preferred Qualifications

• Experience building a pharmaceutical development department or major development function from the ground up.

• Experience working within small to mid-sized pharmaceutical companies where individuals operate with significant responsibility and accountability.

• Experience evaluating:

• Drug shortage opportunities

• Hospital products

• Generic products

• 503B marketplace opportunities

• Experience with ophthalmic products, oral dosage forms, depot formulations, implantables, or related dosage forms.

• Successful technology transfer experience from development into commercial manufacturing.

• Experience establishing portfolio management and stage-gate decision-making systems.

• Experience supporting approved NDA and/or ANDA products.

• Experience balancing scientific, regulatory, manufacturing, and commercial considerations when making development decisions.

We are seeking a leader who is

• Entrepreneurial and practical.

• A builder of organizations, systems, and people.

• Comfortable operating in a growth-oriented environment.

• Highly collaborative and capable of integrating Quality, Regulatory, Manufacturing, Engineering, and Executive leadership perspectives.

• Strategic in thinking yet hands-on in execution.

• Capable of balancing scientific, regulatory, operational, and commercial considerations.

• Motivated by creating long-term organizational capability rather than simply managing projects.

• Comfortable making decisions with incomplete information and limited resources.

• Excited by the opportunity to build something lasting.

Compensation and Benefits

We recognize that building a world-class pharmaceutical development organization requires exceptional leadership.

Compensation will be competitive and commensurate with experience, qualifications, and demonstrated success.

Compensation

Competitive base salary.

Long-term growth and leadership opportunities.

Benefits

Medical, dental, and vision insurance.

401(k) plan.

Paid vacation and holidays.

Life and disability insurance.

Professional development and continuing education support.

Why This Opportunity Is Different

This position offers the opportunity to build upon an established pharmaceutical platform rather than a startup operation.

• Has more than 50 years of operating history.

• Has continuously manufactured and marketed commercial pharmaceutical products since 2002.

• Has successfully developed, approved, manufactured, and commercialized NDA and ANDA products.

• Operates FDA-registered pharmaceutical manufacturing facilities.

• Maintains established Quality, Regulatory, Manufacturing, and Commercial infrastructure.

• Has identified multiple near-term development opportunities and is committed to expanding its pharmaceutical portfolio.

• Is investing in the future growth of its development capabilities and product pipeline.

The Director of Pharmaceutical Sciences and Product Development will have the opportunity to shape the future direction of the company's development organization, product pipeline, and commercialization strategy while working closely with executive leadership.

This is a rare opportunity for an accomplished pharmaceutical development leader to build a lasting organizational capability and play a central role in the next stage of growth for an established and successful pharmaceutical company.

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