RK Pharma Inc., a US based company and its subsidiaries, Apicore LLC (US), Apicore Pharmaceuticals Pvt Ltd (India), Archis Pharma LLC (US), Archis Pharma Europe LTD (Ireland, Europe) and Aktinos Pharma Pvt. Ltd (India). are dedicated to developing and manufacturing Sterile Injectables and Sterile ophthalmic drug products (ANDAs). Our US facilities are in Pearl River, New York, USA (a former Pfizer Facility) and North Brunswick, New Jersey. Our active pharmaceutical ingredients (APIs), along with the related basic and advanced intermediates, are produced at our facilities in several Indian locations. We market these chemicals to pharmaceutical customers worldwide. The group’s commercial arm, Archis Pharma LLC and Archis Pharma Europe LTD, sell the finished drug products under their own labels in US and Europe, respectively. The Company currently enjoys a double-digit annual growth rate which should expand due to several business initiatives undertaken in the past year. In order to manage this growth track, we are currently in search of the following openings to join our growing team.

 

 

Manager Quality Assurance

The Manager Quality Assurance has to manage the development, establishment, and maintenance of Quality Systems, policies, processes, procedures and controls ensuring that performance and quality of cGMP documentation and records conforms to established standards and will be directly reporting to Executive Vice President Quality

Main Responsibilities:

• Manage organizational quality with established SOPs and processes (Deviations/Investigation, CAPA, Quality/Operational Risk Management, Change Control, Quality Metrics, Internal Audits, External Vendor Audits, and Inspection Readiness)
• Manage the Inspection Readiness Program and oversee the execution of regulatory audits and tracking of responses to ensure progress. Compiles all regulatory inspection observations/findings and monitor for signals and trends.
• Assist in the management and logistics of third-party inspection related activities.
• Manage the Internal and External Audit Schedules/Programs and oversee the execution of the remediation responses to ensure progress. Compiles all audit findings and monitor for signals and trends.
• Manage the Vendor Management System, which includes the vendor approval and qualification process, maintenance of the Approved Vendor List, and oversee the management for creation/response to vendor questionnaires.
• Oversee Quality Operations (incoming inspection, in-process testing).
• Drive consistent reporting of appropriate Quality Management System and other applicable metrics.
• Establish and monitor quality metrics for GMP related functional areas within the organization. Issue monthly reports. Escalates significant issues to executive management, as required.
• Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
• Promote a quality mindset within Quality and throughout RK Pharma by ensuring consistent, risk-based, and innovative thought processes are employed to advise and make decisions.
• Communicate milestones and planned changes to the user community regarding Quality System and Compliance initiatives.
• Provide operational management for the functional team.
• Train team members and/or coordinate training for the facility including but not limited to annual cGMP training.

Knowledge, Skills & Technical Expertise:

• In-depth knowledge of aseptic processing, isolator experience a plus.
• In depth knowledge of GxP regulations. Strong knowledge of good regulatory compliance practices, policies, and procedures.
• A strong customer focus and ability to prioritize and adapt to business needs are required.
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
• Extensive knowledge of risk assessment strategies and tools. Ability to identify and mitigate risks.
• Extensive knowledge of investigation techniques and tools.
• Demonstrated ability to work across functions at all levels where the incumbent may not have direct authority to accomplish objectives.
• Ability to make independent sound decisions and independently manage priorities in alignment with customer and company objectives.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Must be a dynamic, hands-on manager with a clear practical understanding of GXPs and the ability to support regulatory inspections, as required.
• Must be able to manage problems of diverse scope using a high degree of personal judgment and must be able to effectively represent RK Pharma
• Ability to effectively mentor and develop staff.
• Problem-solver with the ability to make difficult decisions under challenging circumstances.
• Excellent knowledge of best practices in manufacturing, packaging, and quality systems.
• Excellent organizational skills.
• Technical knowledge of pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management.
• Prior experience with Master Control software is a plus

Supervision:

• Work under general supervision to meet company goals

Measurement of Performance:

• Maintain a Positive, professional attitude toward work and willingness to cooperate with peers and to contribute to a project team
• Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations.
• Demonstrate timeliness and accuracy in completion of projects and paperwork
• Contribute to right first time and on-time delivery of assigned projects
• Demonstrated understanding and adherence to regulatory policies, safety procedures and cGMPs
• Ability to succeed in a team-oriented environment under very dynamic conditions

Qualifications:

• Bachelor’s degree in Scientific or engineering discipline required.
• Advanced scientific, technical, or business degree a plus.
• Minimum of 5-7 years of experience in cGMP and pharmaceuticals/biopharmaceuticals or related industries with a concentration in one of more of the following functions: Quality, Quality Systems, Regulatory or Regulatory Compliance.
• 3+ years managerial experience.
• Cleanroom/Aseptic Area experience required
• Must be detail oriented, conscientious and be a dependable self-starter

 

Microbiologist

The Microbiologist performs technical microbiological and Environmental Monitoring duties to support manufacturing activities and will be directly reporting (Direct line) to Supervisor/Manager of QC Microbiology and (Dotted line) to Associate Director/Director of QC Microbiology

Main Responsibilities:

• Complies with all cGxP and safety requirements and laboratory Standard Operating Procedures
• Perform Environmental Monitoring associated with manufacturing area. Monitoring includes total particulate monitoring, viable air sampling, surface plating of the classified areas, and personnel monitoring.
• Collect WFI, Pure Steam and Purified Water samples associated with the manufacturing areas and subsequently test the samples for presence of bioburden and endotoxin.
• Perform routine laboratory duties to support the overall function of the microbiology laboratory such as preparation of autoclave loads, biosafety cabinet, growth promotion, microbial identification and laminar flow hood cleaning and maintenance.
• Perform routine biological laboratory assays such as pH and buffer preparation as specified in appropriate SOPs.
• Perform Sterility Testing and must be familiar with Isolator technology
• Develop and perform validation methods
• Support Technical Services with Qualification studies

Knowledge, Skills & Technical Expertise:

• Must be able to work in a controlled environment requiring specified gowning
• Must be able to work overtime as needed
• Must be able to work weekends as needed
• Understanding of intermediate Microbiology and Aseptic Behavior

Supervision:

• Work under general supervision to meet company goals

Measurement of Performance:

• Maintain a Positive, professional attitude toward work and willingness to cooperate with peers and supervisors and to contribute to a project team
• Demonstrate timeliness and accuracy in completion of projects and paperwork
• Contribute to right first time and on-time delivery of assigned projects
• Demonstrated understanding and adherence to regulatory policies, safety procedures and cGMPs
• Ability to succeed in a team-oriented environment under very dynamic conditions

Qualifications:

• Bachelors of Microbiology or Biological Sciences and five to seven (5-7) years of related laboratory experience in the pharmaceutical industry; or an equivalent combination of training and experience.
• Cleanroom/Aseptic Area experience preferred
• Must be detail oriented, conscientious and have a high reading comprehension skill.

 

Chief Financial Officer (CFO)

The Chief Financial Officer will be reporting into the CEO of the Company and will be responsible for overseeing the financial function of the parent, RK Pharma Inc., and all its subsidiaries and affiliates. This position will become an integral part of the senior management team. It is expected the CFO will be involved in strategic decision making and managing the Company’s financial resources and accounting and treasury practices. This CFO position will be responsible for the operations of the finance departments in multiple locations worldwide but will be based out of North Brunswick, NJ.

Duties and Responsibilities will include but are not limited to the following:

• Provide overall financial direction to group companies to fulfill their obligations and in carrying out their financial objectives including the development of an annual budget
• Interface with Board of Directors, Committees and Senior Management regularly concerning financial statements and overall financial state of the companies including any significant measures and requirements
• Preparation of monthly financial statements for distribution and review by management and the Board of Directors of the Company
• Coordination of any and all annual internal and external audits of the company’s financial statements
• Synchronize and lead finance/accounting projects, including the development and implementation of an inventory costing system and developing and implementing processes surrounding the consolidation of all subsidiaries to the parent RK Pharma Inc. level
• Contribute to strategic planning and incentive plans for operational improvements
• Preparation of month, quarter and annual financial statements in accordance with US GAAP or IFRS and notes to the financial statements as required ensuring accuracy and timeliness
• Development of an annual budget for the Company and reporting on budget to actual variances
• Management of accounting staff
• Oversight of finance and accounting processes and functioning of internal controls for the companies
• The candidate should be equipped with the knowledge and should be able to analyze and recommend business cases for investment decisions and to manage Capex and investment programs

Qualifications

• CPA designation is preferred.
• Knowledge of international financial systems, along with especially those of India is heavily preferred
• Minimum of 5 years of direct financial and operational experience in a management role.
• Advanced proficiency in Microsoft Office programs including experience with QuickBooks and other financial systems
• Exceptional knowledge of financial reporting and budgeting for mid-sized company
• Excellent communication and relationship building skills and the ability to work with an international team
• Knowledge or experience of the Pharmaceutical Industry shall be an asset to Qualify for the position