Frontida is actively recruiting innovative and caring professionals. Here, you can help develop and build a culture of caring, accountability and continuous improvement (both individually and corporately). Frontida careers extend from pharmaceutical formulation scientists to quality assurance specialists, information technology to regulatory compliance professionals, and manufacturing to mechanical specialists. Join a powerful, results-oriented team.

Job Summary

This position works independently to conduct technical service, product and process development and optimization studies of pharmaceutical products such as immediate release or extended release solid oral dosage forms.  Has overall responsibility for the relaunch and  technology transfer of a product from pilot to commercial manufacturing in conformance with regulatory requirements (FDA, cGMP, DEA, etc.), and is responsible for designing, conducting and coordinating scientific studies for the physical/chemical characterization and pharmaceutical development.

Responsibilities

  •  Responsible for designing, conducting and coordinating scientific studies for physical/chemical characterization and pharmaceutical development.
  • Perform relaunch and scale up development and optimization of manufacturing process based on regulatory guidelines related to pharmaceutical development (such as ICH Q8, Q9 & Q10).
  • Collaborate with R&D formulator and technicians regarding the design and execution of pilot and commercial process parameters, creation of formulation spread sheets, master batch record writing, batch execution, and post batch evaluation and analysis.
  • Executes experiments at lab scale and commercial scale to implement the use of quality by design (QbD) principles and design of experiments (DOE) to develop robust process parameters. Design the experiments using statistical software.
  • Evaluate retrospective quality by design (QbD) assessments of currently marketed products to improve quality, efficiency and mitigate potential cGMP and quality risk.
  • Review batch records, incident investigation reports, change controls, market complains, annual product review, product development protocols and reports, drug master files, validation documents, equipment qualification reports, technology transfer dossiers, stability data, raw material data trend, CAPAs, in process and finished product analytical data for understanding the process knowledge and identify the risks to the quality of the product.
  • Communicates to management an overview of products under development, and their stage of development.
  • Ensures compliance with all aspects of cGMP’s.
  • Assist Engineering staff for facilities design and equipment qualifications.
  • Assist Operations, Quality and Regulatory Affairs units as necessary.
  • Support R&D formulation development, Process Engineering, QbD, Scale up, Technical Service, Cleaning Validation, Process Validation, and Stability activities as mandated by cGMP’s policies/procedures and quality standards.
  • Review, as necessary, all pertinent NDA / ANDA documentation, cleaning procedures, batch history, and technical transfer reports prior to validation and/or scale up activities.
  • Prepare, approve & execute all necessary documentation, reports, protocols, batch records, etc. as required.
  • Perform process improvement projects and troubleshoot production processes.
  • Review SOPs and performance goals to ensure they reflect a commitment to quality and efficiency.
  • Perform other duties as assigned.

Qualifications

  • Bachelor’s Degree in a Science field, Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines, with a minimum of 6+ years related experience and/or equivalent combination of education and experience in Pharmaceutical Development/Validation/ Manufacturing.
  • Good understanding of pharmaceutical unit operations such as blending, milling, compression, tablet coating and fluid bed coating process.
  • Experience with development of immediate and modified release technologies including matrix and pellet formulations is required.
  • Working knowledge of manufacturing equipment and/or minimal formulation knowledge is required.
  • Excellent oral and written communication skills required.
  • To perform this job successfully, an individual must be proficient in each essential duty and the ability to work with minimum supervision.
  • Thorough knowledge of regulatory filing requirements and the impact of guidance’s in streamlining the technical/ process operations is essential.
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Knowledge and Skills

  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical / process procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

Computer Skills:

  • Ability to use PC based software programs (e.g. Microsoft® Word & Excel) and statistical programs (e.g. JMP®, MiniTab®, etc) is a plus.
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)

Physical Demands:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • While performing the duties of this job, the employee is frequently required to stand, talk and hear.
  • The employee is required to walk, climb ladders and scaffolding, sit, use hands to finger, handle, manipulate small objects, and to feel, to reach with hands and arms, to climb or balance, to stoop, kneel, crouch, or crawl, to enter confined spaces through openings, and to taste.
  • The employee must regularly lift and /or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, the ability to determine visual density, and the ability to adjust focus.
  • The employee must be able to smell and to discern differences in odors.

Work Environment:

  • While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts.
  • The employee is occasionally exposed to wet and/or humid conditions, odors, vibrations, low light, high light, high places (on the roof, scaffolding, or ladders), confined spaces, and outside weather conditions.
  • The noise level in the work environment is usually moderate.

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Human Resources Generalist /Payroll Specialist will provide direct support to the Director of Human Resources in the day- to-day administration, communication, and implementation of human resource activities for the organization. The Human Resources Generalist /Payroll Specialist will ensure accurate processing and recording of company’s payroll.

Responsibilities

Payroll:
• Execute the bi-weekly payroll functions in compliance with external regulations and internal policies for the entire organization; including entering of data into payroll software, changing recurring earning and deductions, maintaining all changes to payroll records, tracking and entering all commissions and bonuses and maintaining PTO plans.
• Process hourly employees’ time and attendance/paid time off from HRIS system, ensuring timecards and hours are properly paid
• Compile and prepares for payroll data changes for new hires, terms, deduction/benefit changes, garnishments, 40lk loans, special payments (stipends), etc.
• Reconcile employee deductions and other liabilities as needed
• Send payroll related files to third party vendors (401(K), etc)
• Assist employees with questions and issues related to Payroll.
• Provide technical support for the Time Keeping System and the Employee/ Manager Self Service applications
• Assess enhancements and upgrade functionality for the HRIS
• Prepare payroll and HR reports
• Maintain integrity of employee data by conducting audits to ensure accuracy.
HR:
• Under the direction of the Human Resources Director, responsible for updating and changing forms and procedures that are dictated by changes in employment laws, labor laws, benefit compliance and facility needs.
• Knowledge and administration of FMLA, CFRA, PDL and other Federal and State leave provisions.
• Responsible for benefit administration to include enrollments, terminations, claims resolution, change reporting, and communicating one-on-one with employees regarding their employee benefits.

• Support recruiting/talent management efforts for a variety of positions within the company
• Comply with federal, state, and local legal requirements by staying abreast on current and new legislation and stays abreast on employment law/regulations as it pertains to the Human Resources department.
• Responsible for the proper entry/processing of HR transactions (including onboarding new hires, terminations, job and personal data changes, organizational changes etc.)
• Assist new hires with new hire paperwork, benefits overview, and HR/Payroll self-service portal overview.
• Make files on all new personnel and compiles and maintains personnel records.
• Conduct periodic audits of employee records, I-9 records, compensation and data within the HRIS.
• Assist with offboarding process for separations including exit interviews, separation paperwork, etc.
• Maintain and distribute current employee information, policy and procedure manuals, and other communication
• Must participate and successfully complete all training as required by the company.
• Perform other duties as assigned.

Qualifications

  • High School diploma with 5+ years relevant work experience. Bachelor’s degree preferred
  • Tech-savvy, with the unique ability to adapt quickly, understand software
  • Proficient knowledge of Federal and State Employment and Payroll laws and practices
  • Proficient in Microsoft Office applications (Word, Excel, Outlook) and business related application packages highly desired, plus the ability to learn company used applications
  • Excellent oral and written communications skills
  • Ability to be flexible and shift priorities in fast paced environment
  • Must have a collaborative, friendly, accommodating personality to service our internal and external customer
  • Must be able to handle all personnel issues/documentation in a confidential manner
  • Strong organizational skills and ability to work independently

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Compliance Specialist  will be responsible for managing the vendor qualification program, conducting performing annual product reviews, collecting metrics across the company, and preparing reports for monthly quality council/management review meetings and other technical reports common to the Compliance Department.

Responsibilities

  • Collects metrics across the company for trending of quality performance
  • Performs annual and quarterly trend reports
  • Authors and reviews Annual Product reviews
  • Performs internal audits to ensure compliance against procedures and regulations
  • Performs external audits for suppliers and service providers
  • Manages the vendor qualification program
  • Provides support for execution of special quality projects to implement quality systems, improvements to meet regulatory requirements
  • Provides support during FDA and other regulatory body inspections
  • Updates Standard Operating Procedures (SOP)
  • Supports other departments as directed which may include:
    • Conducts investigative analysis of non-conformance events in the Quality Control laboratory
    • Assigns and communicates corrective and preventive actions (CAPA) to responsible departments based on root cause analysis

Qualifications

  • Bachelors Degree in a lie science such as Chemistry, Microbiology, Biology or related scientific field supplemented with 2-4 years Quality Experience in pharmaceutical industry.
  • Some knowledge of cGMP, FDA and OCHA regulations.
  • Proficiency in Microsoft Office applications (Word, Excel, Outlook, Access) and business related application packages.
  • Experience with Quality Event Management software

 

Knowledge and Skills

  • Strong analytical skills, with an ability to use scientific knowledge and statistical methods to identify potential problems and trends.
  • Ability to organize and write scientific reports
  • Good project management skills
  • Strong computer skills and knowledge of word processing software and spreadsheet software
  • Competent in leading meetings, investigations and team projects
  • Competent in pharmaceutical compliance and regulatory policies
  • Knowledge of pharmaceutical industry guidelines, trends and practices
  • Act with professionalism and treat others with respect and consideration regardless of their status or position
  • Ability to gather information from multiple sources and coordinate and analyze their impact on each other
  • Previous completion of cGMP training

 

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Sr. Manager/Auditor, Compliance and Quality Systems will have the responsibility for managing and leading functions that include but are not limited to investigations, training, internal auditing, quality oversight of validation (process and computer), metrics and quality council primarily for Frontida PA and for Frontida Aurora where processes are shared across sites.

 

Responsibilities

  • Responsible for leading the compliance processes and quality systems including investigations, training, internal auditing, quality oversight of validation (process and computer), and metrics reporting.  Ensure these processes are designed and executed according to cGMP, company SOPs and applicable regulations.
  • Collect metrics across the company for trending of quality performance, identification of trends and improvement opportunities
  • Lead the quality council management review meetings by presenting metrics, quality initiatives and driving quality improvement across the organization
  • Manage direct reports and team, drive a high performing organization, develop personnel for current and future roles within Frontida
  • Provide Quality support for electronic system integration
  • Collaborate across sites to develop common processes and procedures where applicable
  • Drive continuous improvement of quality systems to proactively mitigate current and future risks to support business needs

Qualifications

  • Bachelor’s degree in in a related discipline with 10-15 years of experience in pharmaceutical quality with broad knowledge of GMPs, solid and oral dosage forms, manufacturing and auditing, required
  • Experience leading teams to improved performance demonstrated through metrics
  • Knowledgeable of cGMPs and regulations pertaining to quality system requirements for oral dosage forms, preferred
  • Experience with quality systems, investigation writing, CAPA, preferred
  • Experienced in conducting internal audits, and preparing for and hosting agency inspections and audits, preferred.

Knowledge and Skills

  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other
  • Willing to invest time and energy in continuous improvement efforts

 

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.