1. Hanife Akin, Ph.D. (US Citizen)
hanife.akin@gmail.com; Cell: (858) 205 9022 - Perris, CA
SR. DIRECTOR OF PHARMACEUTICAL MANUFACTURING (OPERATIONS)
Pro-active, Performance-driven, Operations Professional with more
than 15 years progressive expertise in leadership and problem solving for
pharmaceutical manufacturing and operations. Keen understanding of
business priorities, genuine team player committed to managing operations
and projects flawlessly while continuing revenue-producing activities.
Subject Matter Expert who provides strategic direction, and technical
expertise for all activities for pre-formulation, formulation, manufacturing,
packaging, process development, scale up, technology transfer, process and
packaging validation, contract manufacturing and Quality By Design
activities within FDA guidelines, cGMP, SOPs and other pertinent
regulatory and compliance requirements. .
Executive with strong hands on experience in complex manufacturing
processes such as fluid bed granulation/drying, coating (fluid bed and pan
coating), high shear granulation, encapsulation (powder, granules and mini
tablets/beads), liquid encapsulation, aseptic fill/finish process, compression,
blending, and packaging (blistering and bottling).
Detail- and Result-oriented Operations Executive with good
communication, organizational, team building, prioritization and time
management skills, who blends strategic thinking with hands on tactical
execution and has the capability to use “out-of-the-box” thinking to solve
many application needs, proactively defines the critical path, anticipates
potential obstacles, and recommends actions to keep projects on track
Cross-functional Communicator easily interfaces with high-profile staff,
vendors, and clients. Versatile, innovative, and loyal management
professional able to see the “big picture” while staying on the top of all the
details.
Analytical Problem Solver who willingly seeks and accepts challenging
assignments, utilizes a systematic, team-based approach to operational
analysis, develops and implements action plans to drive continuous
improvement.
Areas of Expertise
Technical Expertise
Executive Leadership
Project Management
Manufacturing
Process Improvement
Pre-formulation
Formulation
Policy/Procedure Development
Team Leadership
Strategic Planning
Statistical Analysis
Staff Management
Training/Development
Budget Control
Solid Dosage
Semi-solids
Biologicals
Packaging
Aseptic Filling
PROFESSIONAL EXPERIENCE
Stason Pharmaceuticals, Irvine, CA – USA 2009- Present
Sr. Director of Pharmaceutical Manufacturing (Operations)
Responsible for commercial and clinical batch manufacturing of solid dosage products, reports to Chief of
Operating Officer (COO), and responsible for directing multiple departments (Manufacturing, Technical
Operations, Qualification Engineering, PPIC-Production Planning and Inventory Control) for cGMP
operations including manufacturing of commercial and clinical batches, scale-up, technology transfer,
qualification and maintenance of manufacturing equipment/areas, warehouse, materials and shipment.
• Provides technical guidance to staff for troubleshooting to daily manufacturing and packaging operations;
processes development and improvement studies; scale up, technology transfer, process validation
activities; equipment qualification; manufacturing related complex investigations; root cause analysis and
risk and impact assessment for manufacturing discrepancies; determining and implementing the corrective
and preventive actions.
• Ensures that Master Production Schedule (MPS) are created and communicated to inter-departments
through daily communication/exchange meetings and that dynamic reactions are given for possible changes
in schedule in order to meet cost effective manufacturing and on time product delivery.
• Manages multiple projects within the scope, assures appropriate communication of project status and
issues; develops timelines, goals and drive development in a cross-functional environment including
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2. Hanife Akin, Ph.D. (US Citizen)
hanife.akin@gmail.com; Cell: (858) 205 9022 - Perris, CA
internal departments, and external clients for seamless project transitions from development to
commercialization to get both Stason and contract products to the market quicker.
• Analyzes the procurement cycle and suggests improvements in planning, co-ordinate and expedite the flow
of work and materials within or between departments according to production schedule.
• Adopts business and continuous improvement objectives into operations strategies, recruits and coaches
highly effective multidisciplinary personnel to ensure scientific excellence and state of the art capabilities
of manufacturing to meet the company’s overall objectives and goals for growth, profitability, productivity,
reliability, product quality and Good Manufacturing Practices (GMP) compliance.
• Organize, plan and coordinate all inventory management activities efficiently and effectively to ensure that
all materials are ready and available for production when needed with as little as possible turnaround time.
• Develops and manages department budgets in accordance with organizational strategies and goals.
• Reviews staffing, capital investments and expensed budget items on a continuous basis to ensure cost
effective and compliance with budget.
• Serves as a member of the company’s senior management team, thereby participating in key decisions, both
strategic and operational, affecting the Company. Participates in recalls, customer complaint deviations, the
FDA and other compliance audits, and preparation of 483 responds to the agency.
• Directs and coordinates various programs such as hiring, training, performance appraisals, salary reviews,
team building, interdepartmental interaction, leadership and supervision, safety, housekeeping, cost
reduction, planning, budgeting, projecting revenues, analyzing cost of production regularly.
• Guided serialization solution decision, vendor selection and implementation plan meetings.
Achievements:
o Successfully commercialized and validated 20 new products.
o Led international Technology Transfer of 5 different products to Asian CMO facilities.
o Increased the production capacity 150% by developing the appropriate infrastructure including
people, training, departments, facilities and equipment, and implemented various operational, cost
controls and profit maximization.
o Established Product Life Cycle Management programs, provided leadership and direction to
Process Improvement Teams thereby increasing the ability to manufacture products with desired
quality attributes, ensure greater regulatory compliance, and decrease variability.
o Increased production capacity by 60% and decreasing downtimes (>90%) by establishing
Equipment Life Cycle and Maintenance Program which included regular monthly preventive
maintenance schedules, an inventory of spare parts, performance and failure history for each
manufacturing equipment.
Eisai Pharmaceutical (Formerly Ligand) La Jolla, CA-USA 2006- 2008
Principle Scientist
Reporting to Director of Operations and responsible for establishing effective relationships with all external
manufacturing organizations (CMOs) to ensure commercial and clinical batches are manufactured on time,
with quality and on budget.
• Led the validation activities on different product dosage forms; a biological drug product which is supplied
in single use vials as a sterile, frozen solution intended for intravenous (IV) administration; a soft gel
capsule containing suspension of micronized drug; and topical gel products, controlled release capsule
product containing beads.
• Led interdisciplinary project teams and team meetings (set agenda, action items, responsibilities, timelines,
milestones, follow-up and implementation) with CMOs for process improvement initiatives, technology
transfer and, validation of manufacturing activities to provide adherence to the agenda.
• Performed process related complex investigations, identified root causes of the manufacturing discrepancy,
evaluated systems for trends and adverse findings, and identified and implemented appropriate CAPA
initiatives to achieve sustainable compliance, high product quality, cost reduction and optimized
manufacturing cycle time.
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3. Hanife Akin, Ph.D. (US Citizen)
hanife.akin@gmail.com; Cell: (858) 205 9022 - Perris, CA
• Provided leadership in the formulation, scale up and technology transfer activities of two modified release
products and successfully transferred the products from Japan to USA.
• Led interdisciplinary project teams with CMOs for the harmonization of the products for US and EU
markets in terms of specifications, raw material and final product release testing.
• Interacted closely with all Contract Service Providers, on business and relationship issues, conflict
resolution, finished product shipping coordination and any other manufacturing supply issue that may arise;
established and maintained good communication with contract manufacturers to complete project goals and
performance standards in a timely and compliant manner.
• Managed and provided technical guidance to the contract manufacturers for the technical transfer and
validation activities, establishing development plans for activities related to laboratory and manufacturing
processes, product dosage, quality, cGMP, collecting and analyzing data and drawing conclusions.
• Acted as Project Manager to manage multiple projects, assured appropriate communication of project status
and issues; developed timelines, goals and drive development in a cross-functional environment including
different Contract Service Providers, Marketing, Operations, Quality, and Regulatory.
• Made sure that all work done in accordance to company policies, procedures and regulations contained in
company cGMP’s, safety standards, SOP’s and housekeeping standards, and state, federal and local laws.
Pharmaceutical Technology Specialist III – Watson Pharmaceuticals, Corona, CA - USA (2002-2006)
• Successfully led teams for commercialization of several IR and modified release products from
experimental trials through scale up, technology transfer, validation by interfacing with R&D, quality,
engineering, manufacturing, regulatory affairs, and other technical disciplines.
• Provided validation and technology transfer leadership on several new and/or existing products with
complex manufacturing processes such as low shear and high shear granulation, encapsulation (powder
and mini-tablets/beads), single/bilayer controlled release tablets, and coating (fluid bed and pan coating).
• Carried out several troubleshooting to manufacturing and packaging areas, process related complex
investigations, identified root causes of the manufacturing discrepancy, proposed solutions, assessed the
impact of discrepancies on products and determined corrective actions/preventive actions.
• Managed, planned and coordinated activities for clinical, submission and commercial batch manufacturing,
including batch record and protocol preparation, resourcing, manufacturing, testing and release.
• Developed a new packaging validation strategy requiring fewer resources while maintaining appropriate
measurement of quality parameters; performed several technical and specialized engineering and efficiency
studies and recommended improvements in manufacturing control systems and process enhancements.
• Prepared, revised and reviewed batch records, protocols, validation master plans, SOPs, CAPA and Change
Control documentations.
• Provided training, mentoring and direction to technicians, manufacturing operators and quality assurance
inspectors with regard to project requirements.
Senior R&D Scientist – Pfizer Consumer Healthcare (Formerly Wyeth), Richmond, VA /USA – (2000-2002)
• Hands-on product development from concept to launch on OTC and dietary products.
• Performed pre-formulation studies (accelerated stability, pH solubility and stability profiles of drugs, drug-
excipient interaction, phase separation); evaluated and recommended physical forms (salts, hydrates,
polymorphs); designed and carried out accelerated stability studies for several dosage forms, and
successfully solved the degradation of the actives, color change problems; Developed new characterization
techniques for an undercolor moisturizer lip balm product containing sunscreens and preservatives.
• Successfully developed a suspension formulation by utilizing two polymers to develop a thixotropic
suspension system containing three actives; Rheological studies were conducted to evaluate the impact of
pH, surfactant, polymer, buffer, and particle-particle interactions on physical stability. Study results were
critically useful in formulation development, and targeted shelf life was met.
• Developed an extended-release mucoadhesive formulation that performed significantly better than a
marketed competitor both in animal and human testing. Increased the overall clarity of the gel formulation
using active-excipient interaction.
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4. Hanife Akin, Ph.D. (US Citizen)
hanife.akin@gmail.com; Cell: (858) 205 9022 - Perris, CA
EDUCATION
Post-Doc Institute of Polymer Science, University of Akron, Akron, OH
Ph.D. Polymer Science, The Middle East Technical University, Turkey
Certificate Professional Qualification in Polymer Science, The University of Ferrara, Italy
M.S. Polymer Science, The Middle East Technical University, Turkey
B.Sc. Chemistry, The Middle East Technical University, Turkey
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