ROULA SAMHOUN, PharmD

** **** ***, ******, **

Phone : 617-***-****

Email : ad0bwk@r.postjobfree.com

Career Narrative:

*- *********** ********** *** **********: Director of Production.

-Led compounding pharmacy operations, ensuring strict cGMP, FDA, and DEA compliance.

-Successfully guided FDA audits, showcasing strong regulatory adherence.

-Established a culture of compliance and proactive risk management.

-Optimized manufacturing processes for timely and quality product delivery.

-Hired and trained personnel on cGMP regulations; creating training materials and SOPs.

2- New Product Development and Project Management: Manufacturing Pharmacist

-Drove new product initiatives, expanding the product portfolio.

-Managed projects, aligning goals and timelines across teams.

-Coordinate production and materials to support production needs.

-Proactively analyzed supply chain issues to minimize production interruptions.

-Ensured regulatory alignment and quality standards.

3- Entrepreneurship and Business Development: Founder/Business Development Manager

-Founded and led a thriving outpatient pharmacy, driving growth.

-Implemented innovative marketing strategies, boosting brand recognition.

-Mentored a collaborative team, achieving a successful sale.

Skills

-Proficient in pharmaceutical and biotechnological principles, with expertise in drug development and bioprocessing.

-Experienced in FDA regulations, cGMP compliance, and international regulatory standards.

-Skilled in conducting efficient internal quality audits and implementing CAPA measures.

-Strong background in bioprocess manufacturing.

-Designing Aseptic Pharmaceutical Manufacturing processes including Media Fill.

-Proficient in analytical methods, method validation, and quality control.

-Proven ability to lead interdisciplinary project teams and ensure timely project completion.

-Innovative problem solver, skilled in continuous quality process improvement and collaboration between multiple stakeholders.

-Accomplished leader with a track record of mentoring and managing high-performing teams; voted leader of the year out of 500 employees.

Experience

Director of Production Advanced Compounding Solutions, Woburn, MA Jul 2021-Present

-Spearheaded and led all aspects of production operations for a dynamic compounding pharmacy, ensuring the highest standards of quality, compliance, and efficiency.

-Developed and reviewed Standard Operating Procedures (SOPs), master formulation records, and administrative policies, aligning them with stringent cGMP, DEA, FDA, and USP 797/800 regulations.

-Championed FDA and DEA onsite audits, showcasing record-keeping, inventory control, and compliance measures.

-Demonstrated remarkable efficiency in authoring, reviewing, and approving SOPs, quality improvement plans, and comprehensive reports such as Corrective and Preventive Action (CAPA) plans, Change Controls, and Non-Conformances.

-Exemplified superior organizational skills by planning and coordinating all manufacturing and compounding processes, ensuring optimal resource utilization and timely product delivery.

-Actively engaged in overseeing production operations, managing production schedules, resource allocation, and quality standards, leading to consistent achievement of production targets.

-Established a culture of rigorous compliance and quality assurance, ensuring strict adherence to CGMP regulations.

-Collaborated closely with regulatory affairs and quality control teams to proactively address any quality or compliance concerns, fostering continuous improvement and proactive risk mitigation.

-Demonstrated exceptional leadership by guiding and motivating a high-performing team, setting clear performance expectations, providing effective coaching, and identifying opportunities for professional growth.

-Proactively managed budgets and resources, forecasting production needs, optimizing resource utilization, and identifying opportunities for cost reduction.

-Fostered effective communication and collaboration with various departments, including Supply Chain, and Sales, to ensure seamless coordination and alignment of business objectives.

-Consistently reported production performance metrics, project updates, and challenges to upper management, enabling implementation of mitigation strategies.

Manufacturing Pharmacist (New Product Development) Advanced Compounding Solutions, Woburn, MA Nov 2020-Jul 2021

-Led the strategic planning and execution of new product development initiatives, expanding the company's product portfolio and market reach.

-Designed and developed comprehensive protocols for the introduction of innovative clinical pharmaceutical commercial product development, ensuring alignment with regulatory guidelines and quality standards.

-Effectively managed timelines and project milestones and addressed challenges for successful manufacturing.

-Played a pivotal role in evaluating raw materials, sourcing suppliers and vendors.

-Monitor compounding process inside the cleanroom and verify all compounding steps including volume and weight calculations throughout the process.

-Leveraged your expertise in pharmaceutical science and quality control to verify the accuracy and completeness of master formulation records, standard operating procedures (SOPs).

-Contributed to the successful product launches, enhancing competitiveness and growth.

Pharmacy Manager Walgreens Pharmacy Jul 2020 – Nov 2020

Oversee all daily pharmacy operations, ensuring compliance with company policies and state/federal regulations.

Maintain a clean and organized pharmacy workspace.

Ensure the pharmacy operates efficiently and meets performance metrics.

Provide patient-centered care by counseling patients on their medications, potential side effects, and drug interactions.

Verify and dispense prescriptions accurately and safely.

Offer recommendations for over-the-counter (OTC) medications and healthcare products.

Collaborate with healthcare providers to optimize patient care.

Schedule and supervise pharmacy personnel, ensuring adequate staffing levels.

Conduct performance evaluations and provide ongoing feedback to team members.

Monitor and maintain pharmacy inventory levels, ordering medications and supplies as needed.

Implement inventory control processes to reduce waste and manage drug recalls.

Ensure that the pharmacy complies with all federal, state, and local laws and regulations.

Maintain accurate and up-to-date records, including prescription records and controlled substance inventory.

Founder/Business Development Manager Retail Pharmacy Dec 2015-Mar 2020

-Founded and led a successful outpatient pharmacy business, showcasing strong entrepreneurship, leadership, and business skills.

-Drove rapid growth through strategic business development, creating a highly respected community pharmacy.

-Implemented patient-centric care with personalized attention, counseling, and proactive engagement for optimal health outcomes.

-Executed innovative marketing strategies, significantly boosting customer traffic and brand recognition.

-Established partnerships with insurance companies, expanding coverage and patient accessibility, expanding contract negotiations.

-Managed and mentored a diverse team of interns and technicians, fostering a collaborative work environment.

-Transformed the pharmacy into a health and wellness hub, increasing daily visits from 10 to 100 within six months.

-Oversaw all operations, including scheduling, inventory, compliance, and achieved a 200% capital gain through a successful sale.

-Move out of country and sold Pharmacy with 100% profit.

Medical Sales Representative & Medical Educator Eli Lilly & Co June 2013-Jul 2015

-Developed new accounts, increased territory sales by 35%, and provided extensive diabetes education.

-Collaborated with healthcare professionals, conducted awareness sessions about Diabetes, and organized events.

Quality Assurance Pharmacist Serum Products Pharmaceutical June 2012-June 2013

-Ensured compliance with GMP, ISO 9001:2015, and regulatory requirements.

-Reviewed stability reports, investigated deviations, and maintained quality control documentation.

Pharmacist - Pharmacy Manager Walgreens Pharmacy April 2008 – August 2011

Education:

Lebanese American University, Beirut- Lebanon, ACPE accredited- Doctor of Pharmacy – 2007

Licenses: Massachusetts licensed pharmacist

Languages:

Fluent Spoken and written English, French and Arabic.

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